Z-1787-2023Class I
CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; Implantable Cardioverter Defibrillators
Medtronic, Inc. / initiated 2023-05-10 / Open, Classified / root cause: manufacturing process
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) began a recall of CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; Implantable Cardioverter Defibrillators on . FDA classified it as Class I and gives the reason as "There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1787-2023
- Classification
- Class I
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Medtronic, Inc.
- Product
- CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; Implantable Cardioverter Defibrillators
- Product code
- NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
- Reason for recall
- There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.
- Root cause tag
- manufacturing process
- FDA root cause
- Under Investigation by firm
- Action
- Medtronic issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its consignees on 05/10/2023 by UPS 2-day delivery or email. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been distributed. The notice explained the problem and the risk and requested the following patient management recommendations: - Prophylactic device replacement is NOT recommended. - Program all HV therapy pathways B>AX in all therapy zones to minimize the risk for this issue. - Prioritize reprogramming patients who have both a history of HV therapy and Rx1 programmed AX>B. - For remaining patients with AX>B programming in any HV therapy sequence, schedule (with appropriate discretion) the next follow-up for in-clinic reprogramming to minimize potential for reduced- or no-energy HV therapies to occur. - Contact Medtronic Technical Services (1-800-929-4043) or your local representative if one of the following is observed as these may be an indication of either a device or lead-related issue: o Reduced- or no-energy HV therapy is displayed in Episode Text (regardless of programmed pathway) o A persistent drop of approximately 50% in RA, RV and LV pacing lead impedance measurements as this may be an indication of increased potential for a future reduced- or no-energy therapy. Update 10/10/2023: Beginning 09/27/2023, Medtronic issued communication via letter to consignees regarding the availability of the revised IFU and SmartSync Software. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been distributed. Consignees are asked to complete and return a confirmation certificate (or equivalent record) confirming they have received the notification.
- Quantity in commerce
- 404 units
- Distribution
- US Nationwide - Worldwide Distribution
- Product codes and lots
- GTIN 00763000178260, Lot Serial Numbers: RTT600077S, RTT600166S, RTT600169S, RTT600064S, RTT600083S, RTT600071S, RTT600042S, RTT600028S, RTT600107S, RTT600034S, RTT600421S, RTT600432S, RTT600434S, RTT600574S, RTT600161S, RTT600054S, RTT600160S, RTT600231S, RTT600431S, RTT600045S, RTT600165S, RTT600022S, RTT600062S, RTT600091S, RTT600195S, RTT600430S, RTT600437S, RTT600438S, RTT600125S, RTT600533S, RTT600427S, RTT600481S, RTT600111S, RTT600128S, RTT600040S, RTT600066S, RTT600046S, RTT600573S, RTT600322S, RTT600076S, RTT600024S, RTT600134S, RTT600150S, RTT600531S, RTT600047S, RTT600086S, RTT600220S, RTT600059S, RTT600063S, RTT600426S, RTT600530S, RTT600075S, RTT600095S, RTT600149S, RTT600537S, RTT600541S, RTT600546S, RTT600549S, RTT600550S, RTT600552S, RTT600716S, RTT600889S, RTT600093S, RTT600057S, RTT600156S, RTT600157S, RTT600037S, RTT600429S, RTT600236S, RTT600422S, RTT600436S, RTT600143S, RTT600507S, RTT600065S, RTT600072S, RTT600435S, RTT600056S, RTT600073S, RTT600098S, RTT600067S, RTT600425S, RTT600081S, RTT600035S, RTT600527S, RTT600087S, RTT600433S, RTT600140S, RTT600167S, RTT600168S, RTT600089S, RTT600103S, RTT600030S, RTT600061S, RTT600420S, RTT600566S, RTT600567S; GTIN 00763000178284, Lot Serial Numbers: RTT600985S, RTT600411S, RTT600879S, RTT600925S, RTT601085S, RTT600918S, RTT600632S, RTT600977S, RTT600367S, RTT600456S, RTT600459S, RTT600389S, RTT600323S, RTT600351S, RTT600453S, RTT600356S, RTT600360S, RTT600377S, RTT600558S, RTT600577S, RTT600547S, RTT600314S, RTT600334S, RTT600522S, RTT600592S, RTT600608S, RTT600609S, RTT600601S, RTT600630S, RTT600631S, RTT600663S, RTT600668S, RTT600669S, RTT600967S, RTT600521S, RTT600948S, RTT600968S, RTT600969S, RTT600315S, RTT600338S, RTT600512S, RTT600346S, RTT600350S, RTT600443S, RTT600482S, RTT600595S, RTT600606S, RTT600329S, RTT600375S, RTT600318S, RTT600310S, RTT600133S, RTT600397S, RTT600518S, RTT600898S, RTT600307S, RTT600414S, RTT600452S, RTT600548S, RTT600587S, RTT600942S, RTT600956S, RTT600962S, RTT600490S, RTT600525S, RTT600536S, RTT600316S, RTT600354S, RTT600361S, RTT600517S, RTT600596S, RTT600640S, RTT600010S, RTT600015S, RTT600016S, RTT600017S, RTT600135S, RTT600142S, RTT600148S, RTT600204S, RTT600330S, RTT600331S, RTT600335S, RTT600342S, RTT600343S, RTT600344S, RTT600440S, RTT600441S, RTT600450S, RTT600454S, RTT600455S, RTT600528S, RTT600551S, RTT600553S, RTT600575S, RTT600646S, RTT600648S, RTT600649S, RTT600958S, RTT600652S, RTT600023S, RTT600964S, RTT600379S, RTT600396S, RTT600617S, RTT600624S, RTT600578S, RTT600457S, RTT600458S, RTT600586S, RTT600498S, RTT600341S, RTT600347S, RTT600381S, RTT600399S, RTT600582S, RTT600583S, RTT600506S, RTT600215S, RTT600308S, RTT600326S, RTT600327S, RTT600368S, RTT600370S, RTT600390S, RTT600580S, RTT600651S, RTT600304S, RTT600359S, RTT600488S, RTT600376S, RTT600378S, RTT600380S, RTT600418S, RTT600419S, RTT600495S, RTT600653S, RTT600661S, RTT600664S, RTT600903S, RTT600904S, RTT600913S, RTT600916S, RTT600929S, RTT600391S, RTT600392S, RTT600406S, RTT600409S, RTT600500S, RTT600503S, RTT600504S, RTT600878S, RTT600910S, RTT600365S, RTT600369S, RTT600371S, RTT600372S, RTT600373S, RTT600374S, RTT600408S, RTT600410S, RTT600412S, RTT600415S, RTT600483S, RTT600485S, RTT600494S, RTT600499S, RTT600529S, RTT600532S, RTT600544S, RTT600563S, RTT600634S, RTT600635S, RTT600636S, RTT600645S, RTT600647S, RTT600885S, RTT600900S, RTT600905S, RTT600667S, RTT600883S, RTT600305S, RTT600451S, RTT600337S, RTT600196S, RTT600309S, RTT600348S, RTT600353S, RTT600355S, RTT600357S, RTT600358S, RTT600382S, RTT600386S, RTT600387S, RTT600388S, RTT600393S, RTT600400S, RTT600401S, RTT600402S, RTT600403S, RTT600404S, RTT600405S, RTT600413S, RTT600416S, RTT600417S, RTT600477S, RTT600478S, RTT600479S, RTT600484S, RTT600487S, RTT600491S, RTT600492S, RTT600493S, RTT600497S, RTT600505S, RTT600509S, RTT600523S, RTT600524S, RTT600534S, RTT600535S, RTT600554S, RTT600556S, RTT600597S, RTT600626S, RTT600627S, RTT600629S, RTT600633S, RTT600637S, RTT600642S, RTT600644S, RTT600656S, RTT600660S, RTT600882S, RTT600884S, RTT600891S, RTT600894S, RTT600896S, RTT600897S, RTT600901S, RTT600908S, RTT600911S, RTT600935S, RTT600345S, RTT600363S, RTT600394S, RTT600398S, RTT600407S, RTT600540S, RTT600559S, RTT600568S, RTT600665S, RTT600666S, RTT600887S, RTT600890S, RTT600906S, RTT600907S, RTT600912S, RTT600983S, RTT600319S, RTT600496S, RTT600579S, RTT600591S, RTT600604S, RTT600607S, RTT600610S, RTT600612S, RTT600613S, RTT600614S, RTT600625S, RTT600881S, RTT600886S, RTT600919S, RTT600920S, RTT600921S, RTT600928S, RTT600934S, RTT600936S, RTT600937S, RTT600939S, RTT600941S, RTT600944S, RTT600945S, RTT600946S, RTT600947S, RTT600957S, RTT600974S, RTT600984S, RTT600988S, RTT601082S, RTT601084S, RTT601086S, RTT601087S, RTT601093S, RTT601094S, RTT601095S, RTT601096S, RTT601098S, RTT601104S, RTT601105S, RTT601106S, RTT601108S, RTT601111S, RTT601127S, RTT600449S, RTT600979S, RTT600620S, RTT600718S, RTT601083S
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1704-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1705-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1706-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1707-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1708-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1709-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1710-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1711-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1712-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1713-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1714-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1715-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1716-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1717-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1718-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1719-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1720-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1721-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1722-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1723-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1724-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1725-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1726-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1727-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1728-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1729-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1730-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1731-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1732-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1733-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1734-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1735-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1736-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1737-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1738-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1739-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1740-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1741-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1742-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1743-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1744-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1745-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1746-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1747-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1748-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1749-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1750-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1751-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1752-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1753-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1754-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1755-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1756-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1757-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1758-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1759-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1760-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1761-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1762-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1763-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1764-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1765-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1766-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1767-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1768-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1769-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1770-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1771-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1772-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1773-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1774-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1775-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1776-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1777-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1778-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1779-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1780-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1781-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1782-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1783-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1784-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1785-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1786-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1787-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1788-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1789-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1790-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1791-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1792-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1793-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1794-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1795-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1796-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1797-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1798-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1799-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1800-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1801-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1802-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1803-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1804-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1805-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1806-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1807-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1808-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1809-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1810-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1811-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1812-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1813-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1814-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1815-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1816-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1817-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1818-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1819-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1820-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1821-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1822-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1823-2023 | Class I | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.