FDA Medical Device Recalls (openFDA)
Covidien, LLC: COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1
- Recall number
- Z-0955-2023
- Recalling firm
- Covidien, LLC
- Product
- COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1
- Status
- Open, Classified
- Initiated
- 2022-11-23
- Posted
- 2023-01-12
- Terminated
- not on file
- Reason
- The product is labeled with the incorrect expiration date.
- Root cause
- Process control
- Action
- On about 11/23/2022, the single customer was notified with an "URGENT: MEDICAL DEVICE RECALL" letter via visit. The letter instructed the consignee to immediately identify, segregate, and quarantine affected products within your inventory, pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred, and to contact Medtronic to return affected product. Additionally. the consignee was instructed to complete and return the customer confirmation form even if you do not have any affected units. Return the form via email to RS.GMBFCAMITG@medtronic.com within 30 days of receipt. Contact us at 1-800-255-6774 to receive a return material authorization (RMA) and coordinate inventory replacement/credit. Return unopened affected units to: Medtronic Attention: [Insert RGA #], 4340 Swinnea Rd, Bldg A Memphis, TN 38118. If you have any questions regarding this communication, please contact your Medtronic Representative or Medtronic Customer Service at 800-962-9888.
- Quantity
- 21 units
- Distribution
- Foreign Distribution: Hong Kong
- Lot, serial or model codes
- UDI/DI (GTIN): 10884521825765, Lot Number: 520200
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NEY
- Firm FEI
- 3004962788
- Firm city
- Minneapolis
- 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