Bolton Medical Inc. recalls RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Part…
The stent-graft inside the delivery system was the incorrect size.
Read the official notice →- Date
- 2024-04-03
- Country
- United States
- Brand
- Bolton Medical
- Product
- RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Part…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of AZ, MA, and TX. The…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Bolton Medical recalls
- 2026-06-03
USBolton Medical Inc. recalls RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U…
Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.
FDA · DeviceBolton Medical Inc.Worldwide - distribution in the US Territory of Puerto Rico and the countries…Official notice →- 2023-06-14
- US
Bolton Medical Inc. recalls The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg…
Potential for the incorrect size stent-graft than the printed carton label.
FDA · DeviceBolton Medical Inc.Worldwide distribution - US Nationwide distribution in the states of FL, NY,…Official notice → - 2023-01-25
- US
Bolton Medical Inc. recalls RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX
The product may be shorter than packaging indicates
FDA · DeviceBolton Medical Inc.Worldwide distribution - US Nationwide and the countries of UK, France,…Official notice →
Other drugs & medical recalls in the United States
- 2024-04-03
- US
Applied Medical Resources Corp recalls Epix Universal Clip Applier, REF: CA500, STERILEEO
Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.
FDA · DeviceApplied Medical Resources CorpWorldwide - US Nationwide distribution including in the states of AK, AL, AR,…Official notice → - US
Philips North America recalls CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.X
It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode.
- US
Olympus Corporation of the Americas recalls SOLTIVE Pro SuperPulsed Laser (TFL-SLS )
A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
FDA · DeviceOlympus Corporation of the AmericasDomestic: OUS Only; International distribution in the states of Australia,…Official notice → - US
DeRoyal Industries Inc recalls GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART
DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled.
- US
Medivance Inc. recalls Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
Neonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling performance of the pads that are part of a temperature management system.
FDA · DeviceMedivance Inc.Worldwide - US Nationwide distribution including in the states of IL, AL, AZ,…Official notice → - US
Baxter Healthcare Corporation recalls Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d) PC1016SNBIO
A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal…
FDA · DeviceBaxter Healthcare CorporationUS Distribution to states of: CT, VA, TX, PA and IL; and OUS (foreign)…Official notice →