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WALLSTENT™ RP Endoprosthesis
BOSTON SCIENTIFIC CORPORATION · Model M001711020 · UDI-DI 08714729406136
JCT
Prescription
10
510(k) clearances
3,007
Adverse events (108 deaths)
61
Recalls
28
Facilities
Description
Self-Expanding Stent
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-03-03 | Atrium Medical Corporation | Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal causing pr |
| 2022-03-03 | Atrium Medical Corporation | Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal causing pr |
| 2018-03-07 | SPS Sterilization, Inc | The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life |
| 2018-03-07 | SPS Sterilization, Inc | The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life |
| 2018-03-07 | SPS Sterilization, Inc | The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life |
| 2018-03-07 | SPS Sterilization, Inc | The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life |
| 2018-03-07 | SPS Sterilization, Inc | The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life |
| 2017-05-25 | Atrium Medical Corporation | Firm received a complaint that a customer who ordered an ADVANTA V12 7mm x 22mm x 120cm received an ADVANTA v12 7 mm x 38 mm x 80 cm, due to the manifold (catheter hub) was printed |
| 2016-03-18 | Boston Scientific Corporation | Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm |
| 2015-02-11 | EXP Pharmaceutical Services Corp | EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were re |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.