FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)
- Recall number
- Z-1593-2023
- Recalling firm
- Boston Scientific Corporation
- Product
- WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)
- Status
- Open, Classified
- Initiated
- 2023-04-05
- Posted
- 2023-05-16
- Terminated
- not on file
- Reason
- The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
- Root cause
- Process control
- Action
- Boston Scientific issued an URGENT MEDICAL DEVICE PRODUCT REMOVAL notice on 04/05/2023 by overnight mail. The notice explained the issue and the hazard and requested the consignee segregate the devices pending return. Medical facilities who distributed the devices and distributors were directed to send the notice to their customers.
- Quantity
- 10833 units
- Distribution
- Worldwide
- Lot, serial or model codes
- GTIN 08714729965770 (outer package), GTIN 08714729965794 (inner package), Batch numbers: 30319836,30359588,30368418,30392647,30409465,30421836, 30442123,30522919,30564343,30577971,30593836,30600837, 30600839,30601021,30616553,30620297,30625219,30638465, 30638467,30638469,30638471,30665570,30666996,30681966, 30681968,30681970,30712588,30725194,30780665,30801487, 30801489,30801491,30811488,30845828,30845830,30845832, 30885087,30890263,30890265,30914070,30922072,30929565, 30935495,30935497,30935499,30981820
- 510(k) numbers
- ["K172453"]
- PMA numbers
- not on file
- Product code
- DTL
- Firm FEI
- 3002095335
- Firm city
- Maple Grove
- 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