—#211876

Product

HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550

FDA product code: KNS — Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K233318
Affected lot / code info: GTIN: 08714729904571 Lot Numbers: 32868212, 32947950, 32998424, 32998425, 33177074, 33177075, 33177077, 33185872, 33185873, 33185874, 33185875, 33185877, 33187647, 33187648, 33195395, 33195397, 33209120, 33209135, 33209138, 33209139, 33209840, 33243859, 33257462, 33257474, 33257477, 33268719, 33278543, 33284513, 33284514, 33284517, 33293229, 33301038, 33301039, 33301341, 33315855, 33315856, 33317299, 33318093, 33527177, 33537640, 33538743, 33577557, 33688060, 33688061, 33747542, 33747543, 33749929, 33749930, 33756082, 33756083, 33765265, 33765266, 33804645, 33805203, 33805205, 33805206, 33805208, 33893271, 33902105, 33933459, 33939639, 33948084, 33986699, 33987798, 33987799, 33988020, 33988021, 33988022, 33988779, 33989320, 34015887, 34028520, 34035525, 34035526, 34035529, 34035530, 34035965, 34044970, 34044971, 34044972, 34044973, 34047717, 34047718, 34047819, 34065662, 34065663, 34065664, 34065665, 34074525, 34074528, 34083208, 34085560, 34085561, 34086663, 34093771, 34095708, 34095710, 34095711, 34116466, 34126531, 34126534, 34126535, 34128862, 34135087, 34135090, 34161836, 34161837, 34161838, 34161839, 34163750, 34163751, 34172106, 34172107, 34180838, 34181501, 34182330, 34190948, 34201919, 34232994, 34232995, 34232997, 34334695, 34334696, 34335369, 34371098, 34372194, 34375171, 34375173, 34381805, 34512950

Why it was recalled

Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.

Root cause (FDA determination)

Process control

Action the firm took

Boston Scientific issued Urgent Medical Device Removal - Immediate Action Required Letter via Fedex Priority Overnight on December 20, 2024 to US consignees. Letter states reason for recall, health risk and action to take: This removal affects only the products listed in Attachment 1. Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. Share this notice with any health care professional within your organization and with any organization where the affected products may have been transferred. " If you are a distributor, this notification must be forwarded to your customers to ensure notification of this product removal is carried out to the end-user level. If you are a facility that has sent products to another hospital or a facility within your network, ensure this notification is forwarded to them. Contact your local Boston Scientific representative with any questions.

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: Nationwide including Puerto Rico Foreign: To be provided

Timeline

Recall initiated: 2024-12-20
Posted by FDA: 2025-01-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #211876. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.