Z-1570-2025Class I
HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental...
Abbott Medical / initiated 2025-03-13 / Open, Classified / root cause: manufacturing process
Thoratec LLC began a recall of HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left Ventricular Assist... on . FDA classified it as Class I and gives the reason as "Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning off/restarting, may cause system controller to indicate Yellow...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1570-2025
- Classification
- Class I
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Abbott Medical
- Product
- HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Rental. Used with HeartMate 3 and II Left Ventricular Assist System.
- Product code
- DSQ Ventricular (Assist) Bypass
- Reason for recall
- Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or turning off/restarting, may cause system controller to indicate Yellow Wrench or No External Power alarms. If MPU losses power, System Controller can support the pump up to 15 minutes, and if not switched to rechargeable batteries, pump may lose power.
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- On 3/13/2025, recall notices were sent to customers who were asked to do the following: If patients are/ and are not able to be identified using the serial number list, send those patients the patient letter. If the MPU is not listed, this device is not affected. For units in use that have experienced MPU power issues: If there is an MPU power failure, transfer the patient from the MPU to the 14V rechargeable batteries within 15 minutes (see IFU). The Backup Battery in the System Controller will temporarily power the pump during a power source switch for up to 15 minutes. MPU will continue to echo the controller alarms as long as the internal AA batteries in the MPU do not need replacement. Do not continue to use the MPU and contact firm's Technical Support at 1-800-456-1477 (8 AM EST to 7 PM EST) for return and replacement. For units in use but not experiencing MPU power issues: Provide patient letter and educate about the issue. Ensure the patient's 14V rechargeables are ready and available for use. Prompt patient to replace AA batteries inside the MPU immediately if the Yellow Mobile Power Unit Battery Indicator alarm is active. Firm will replace these with new units starting June 2025. Return/replace units not distributed, not in use, on shelves, or that are unopened. Contact Customer Support at 1-612-444-3013, Option 2 (9 AM EST to 6:30 PM EST). Complete/return the acknowledgement form via email to [email protected] Distribute this notice to those who need to be aware within your institution and to any organization to which these devices may have been transferred. Device lookup tool with the impacted MPU devices, available by March 24th, 2025: https://www.cardiovascular.abbott/us/en/hcp/products/heart-failure/left-ventricular-assistdevices/ heartmate-3/indications-safety-warnings/advisories.html by March 24th, 2025. If you have questions, contact Technical Support.
- Quantity in commerce
- 1661
- Distribution
- Worldwide - US Nationwide distribution in the states of WA, NE, VA, PA, DC, KY, CA, IL, WI, TX, MA, AR, MS, MI, OH, FL, NC, TN, LA, NJ, UT, NY, DE, CT, GA, IN, AZ, OK, MO, OR, MN, SC, NM, MD, IA, KS, AL, CO, ME and the countries of ALGERIA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CHILE, CZECH REPUBLIC, FINLAND, FRANCE, GEORGIA, GERMANY, HONG KONG, ISRAEL, ITALY, JAPAN, KUWAIT, LEBANON, LITHUANIA, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, POLAND, PORTUGAL, ROMANIA, SERBIA, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UK, UNITED ARAB EMIRATES.
- Product codes and lots
- UDI-DI: 05415067038234. MPUs distributed between April 2024 and February 2025. 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20285508, 20285551, 20285552, 20285555, 20285557, 20285559, 20285564, 20285566, 20285567, 20285568, 20296506, 20296511, 20296512, 20296513, 20296514, 20296517, 20296518, 20296520, 20296523, 20296524, 20296529, 20296530, 20296536, 20296537, 20296539, 20296540, 20296541, 20296543, 20296544, 20296545, 20297139, 20297142, 20297144, 20297145, 20297146, 20297148, 20297150, 20297169, 20297170, 20297172, 20297173, 20297174, 20297175, 20297177, 20297178, 20297179, 20297180, 20297184, 20297185, 20297186, 20300902, 20300908, 20300909, 20300912, 20300913, 20300914, 20300915, 20300916, 20300919, 20300920, 20300921, 20300923, 20300924, 20300925, 20300936, 20300939, 20300940, 20300943, 20307745, 20307746, 20307750, 20307751, 20307757, 20307760, 20307764, 20307766, 20307767, 20307772, 20307775, 20307776, 20307778, 20307806, 20307807, 20307808, 20307809, 20307810, 20307811, 20307812, 20307813, 20307839, 20307840, 20307841, 20326865, 20326867, 20326868, 20326869, 20326870, 20326872, 20326873, 20326876, 20326877, 20326878, 20326879, 20326918, 20326921, 20314704, 20314705, 20314707, 20314710, 20314711, 20314713, 20314706, 20314709, 20314712, 20242028, 20242029, 20242030, 20242031, 20242032, 20242033, 20242034, 20242035, 20242036, 20242037, 20254073, 20254074, 20254075, 20254076, 20254077, 20254078, 20254079, 20254080, 20254081, 20254082, 20254113, 20254114, 20254115, 20254116, 20254117, 20254120, 20254121, 20254122, 20300926, 20300927, 20300928, 20300929, 20300930, 20300931, 20300932, 20300933, 20300934, 20300935, 20307734, 20307736, 20307743, 20254118, 20254119, 20307735, 20307737, 20254089, 20277239, 20296525, 20296534
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1570-2025 | 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.