Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm),
Summary
The FDA issued a Class I for Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm by IMPERATIVE CARE INC. Reason: There is a potential for distal end of catheters to fracture and become detached..
Details
Source
Device Recall
External ID
Z-2577-2021
Action Date
2021-10-06
Status
Completed
Category
device
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.
Lot/Code Info: 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
Quantity Affected: 3118 units
Reason for Recall
There is a potential for distal end of catheters to fracture and become detached.
Distribution
US nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-13
Company
Campbell, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 201 device recalls issued in the same week, part of 403 device-related FDA actions this month.
IMPERATIVE CARE INC has 12 FDA actions in our database, including 1 recall and 11 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (IMPERATIVE CARE INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does IMPERATIVE CARE INC have FDA actions?
IMPERATIVE CARE INC has 12 FDA actions in our database, including 1 recall and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2577-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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