AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H 105650-001R 105650-001Z 105650-002R 105650-004H
FDA device recall Z-0717-2020 · posted 2019-12-19 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Missing Directions for Use (DFU) - Consoles shipped to customers without the required Operator's Manual.
- Action taken
- Boston Scientific Customer issued notification letters dated 11/08/19 via overnight mail delivery. Letter states reason for recall, health risk and action to take: AngioJet Repaired Consoles located at affected accounts will remain in the field. An AngioJet DFU will be provided to accounts to correct the previous DFU omission with the distribution of the Repaired Console. Your local Sales Representative can answer any questions that you may have regarding this correction. Please pass this notice to any healthcare professional from your organization who needs to be aware and to any organization where these devices have been transferred (if appropriate).
- Root cause
- Reprocessing Controls
- Status
- Terminated
- Product code
- MCX
- Quantity affected
- 169 units ((OUS: 44 US: 125)
- Distribution
- Worldwide distribution - US Nationwide distribution and country of Canada.
- Date initiated
- 2019-11-08
- Date posted
- 2019-12-19
- Date terminated
- 2021-03-24
- Location
- Marlborough, MA
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