FDA Medical Device Recalls (openFDA)
IMPERATIVE CARE INC: 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.
- Recall number
- Z-2577-2021
- 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.
- Status
- Completed
- Initiated
- 2021-08-13
- Posted
- 2021-09-29
- Terminated
- not on file
- Reason
- There is a potential for distal end of catheters to fracture and become detached.
- 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 return@imperativecare.com. 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
- 3118 units
- Distribution
- US nationwide distribution.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K183043","K202182","K210996"]
- PMA numbers
- not on file
- Product code
- NRY
- Firm FEI
- 3014590708
- Firm city
- Campbell
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28