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Imperative Care, ZOOM 71 Reperfusion Catheter, REF:… recallZ-2577-2021 · Imperative Care Inc · initiated Aug 13, 2021

Class I Completed All recalls posted in September 2021

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Imperative Care Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

There is a potential for distal end of catheters to fracture and become detached.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-2577-2021
Recall class
Class I (most serious)
Status
Completed
Initiated by the company
Aug 13, 2021
Posted by the FDA
Sep 29, 2021
Recalling firm
Imperative Care Inc
Quantity
3118 units
Product code
NRY
FDA submissions
K183043, K202182, K210996
Distribution
US nationwide distribution.

Product description

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.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

7 devices cleared under K183043, K202182, K210996 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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