Z-2577-2021Class I

Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071...

Name: Z-2577-2021 Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071...
Creator: Imperative Care Inc
Published: 2021-08-13
License: https://open.fda.gov/license/

Imperative Care Inc. / initiated 2021-08-13 / Completed

FDA source

IMPERATIVE CARE INC began a recall of Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx Only, UDI: (01)... on 2021-08-13. FDA classified it as Class I and gives the reason as "There is a potential for distal end of catheters to fracture and become detached". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-2577-2021
Classification: Class I
Status: Completed
Initiated: 2021-08-13
Posted: 2021-09-29
Recalling firm: Imperative Care Inc.
Product: Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx Only, UDI: (01) 00812212030191. For neurovascular procedures.
Product code: NRY Catheter, Thrombus Retriever
Reason for recall: There is a potential for distal end of catheters to fracture and become detached.
FDA root cause: Under Investigation by firm
Action: On August 18, 2021 , Imperative Care issued a "Urgent: Voluntary Medical Device Recall" Notification to all affected healthcare facilities. In addition to informing consignees about the recalled product, Imperative Care ask consignees to take the following actions: 1. Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall. 2. Immediately review your inventory for the specific lot numbers listed within the recall notification . 3. Remove and quarantine all unused affected products in your inventory. 4. Return the potentially affected products to Imperative Care. Your local Imperative Care Sales Representative can assist in facilitating the return of product as necessary. 5. If replacement product is needed, your Imperative Care Sales Representative can assist you with identifying suitable replacement product. 6. Complete the attached Customer Confirmation Certificate and contact your local Imperative Care Sales Representative. 7. Please ensure that the attached Customer Acknowledgement Certificate is returned within 3 business days to acknowledge receipt within your Department/Facility. This may be a requirement within your healthcare organization. 8. If you have any questions regarding this voluntary recall, please contact Imperative Care Customer Service at 1-408-502-7548, your Imperative Care Sales Representative, or email us at [email protected]. 9. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Quantity in commerce: 3118 units
Distribution: US nationwide distribution.
Product codes and lots: Affected Lots: V2014902, F2026201, F2026802, F2028801, F2028901, F2029501, F2029701, F2030801, F2031101, F2035301, F2032502, F2100802, F2101301, F2104102, F2108101, F2108801, F2109601, F2109701, F2111101, F2110601, F2112301, F2113004, F2112001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2577-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2577-2021	Class I	Completed	Voluntary: Firm initiated	2021-10-06	2021-09-29

Product code NRY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)