FDA Medical Device Recalls (openFDA)
Abbott: FIRMap" Catheter, 60mm Basket
- Recall number
- Z-1213-2022
- Recalling firm
- Abbott
- Product
- FIRMap" Catheter, 60mm Basket
- Status
- Terminated
- Initiated
- 2022-04-28
- Posted
- not on file
- Terminated
- 2024-06-18
- Reason
- Incorrect product labeling.
- Root cause
- Process control
- Action
- The firm sent out a "MEDICAL DEVICE RECALL" notification letter dated 04/28/2022 via hand delivery to the US customers. OUS consignee notification is via hand delivery. A copy of the English version of the OUS letter is attached and this letter was translated into the appropriate languages for delivery. The letter instructs the consignee to stop using the remaining inventory, complete and return the acknowledgement form by email: EPCcompliance@abbott.com, and return all unused devices. Should you have questions about this issue, please contact your local Abbott Representative or Abbot Support at 1-888-655-3500 (Option 2) (U.S.), 8:30 a.m. - 5:30 p.m. Central Time Monday through Friday.
- Quantity
- 40 units
- Distribution
- US Nationwide Distribution to states of: MO, CA, OH, WA and OUS internationally to Italy and Netherlands.
- Lot, serial or model codes
- Model Number: AR064060; UDI Number: ( 01) 0 0810591 02002 4 ( 17) 020531 ( 00) 1 2345678 95; Batch Numbers: 2158303 (Exp. Date: 30 NOV 2022), 2159876 (Exp. Date: 31 JAN 2023), 2156510 (Exp. Date: 30 SEP 2022), 2162996 (Exp. Date: 31 MAR 2023), 2159875 (Exp. Date: 30 NOV 2022), and 2159877 ( Exp. Date: 30 NOV 2022).
- 510(k) numbers
- ["K142182"]
- PMA numbers
- not on file
- Product code
- MTD
- Firm FEI
- 3005334138
- Firm city
- Plymouth
- Firm state
- MN
- 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