FDA Medical Device Recalls (openFDA)
Medtronic: SCHRITTMACHER ANGIO X3; Item Number: 4045255423347
- Recall number
- Z-2548-2017
- Recalling firm
- Medtronic
- Product
- SCHRITTMACHER ANGIO X3; Item Number: 4045255423347
- Status
- Terminated
- Initiated
- 2017-05-03
- Posted
- not on file
- Terminated
- 2019-07-18
- Reason
- Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
- Root cause
- Process control
- Action
- All consignees were notified via Federal Express or certified mail on May 3, 2017, and the letter informs customers of the potential for an incomplete seal on the inner package and the actions they should take. Customers are requested to acknowledge receipt and understanding of the Urgent Field Corrective Action Notice.
- Quantity
- 478,465 (total for all products)
- Distribution
- Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.
- Lot, serial or model codes
- 228111X
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GAM
- Firm FEI
- 1219930
- Firm city
- North Haven
- Firm state
- CT
- 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