Device recall: FIRMap" Catheter, 60mm Basket
FDA enforcement event 90106 is a device recall by Abbott of Plymouth, MN, initiated 28 Apr 2022 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 18 Jun 2024. Initiation: voluntary: firm initiated. Abbott has 13 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Abbott, Plymouth, MN.
Reason for recall
"Incorrect product labeling."
Distribution
"US Nationwide Distribution to states of: MO, CA, OH, WA and OUS internationally to Italy and Netherlands."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1213-2022 | FIRMap" Catheter, 60mm Basket | 40 units | Class II | Terminated | 8 Jun 2022 |
Context
Other enforcement events for Abbott
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Incorrect product labeling."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide Distribution to states of: MO, CA, OH, WA and OUS internationally to Italy and Netherlands."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 18 Jun 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.