The Recall Desk
HighFDA (Devices)·Z-1689-2023·Announced 2023-06-14

TREO Abdominal Stent-Graft Label Does Not Match Actual Device Size

Bolton Medical is recalling the TREO Abdominal Stent-Graft System because the carton label may not match the actual stent-graft size inside. Implanting the wrong size stent-graft could result in surgical complications.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a high-risk surgical implant where incorrect sizing could result in serious surgical complications. However, no illnesses or injuries have been reported, making this a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Bolton Medical is recalling the TREO Abdominal Stent-Graft System due to a potential mismatch between the actual stent-graft size and the size printed on the carton label. The device is an implantable vascular graft system used in surgical repair of abdominal aortic aneurysms, consisting of a main bifurcated stent-graft and extension components.

The risk is that surgical personnel may inadvertently select or implant an incorrect size stent-graft if they rely on the carton label without confirming the actual device dimensions. Using a mismatched size stent-graft during implantation could result in improper placement, inadequate aneurysm exclusion, or failure of the device to function as intended.

The recall affects 216 units distributed worldwide, including U.S. locations in Florida, New York, Virginia, and Washington, as well as international locations in Italy, Great Britain, and Switzerland. Multiple lot numbers across different stent-graft configurations are affected.

Healthcare facilities, surgeons, and staff should verify the actual size of each TREO stent-graft device before surgical use rather than relying solely on the carton label. Contact Bolton Medical for clarification if device size does not match the carton labeling.

The recalled product

Product
The TREO ABDOMINAL STENT-GRAFT SYSTEM (TREO) consists of four types of implants, specifically a Main Bifurcated Stent-Graft, a Leg Extension Stent-Graft, a Proximal Cuff Stent-Graft and a Straight Iliac Extension Stent-Graft. Each stent-graft is preloaded into its own delivery s
Manufacturer
Bolton Medical Inc.
Category
Medical Device — Abdominal Stent-Graft
Hazard
Affected units
216

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • a. GTIN Number: 00843576151963
  • Catalog Number (Lot Number): 28-S2-13-080U (2104270154)
  • b. GTIN Number: 00843576151994
  • Catalog Number (Lot Number): 28-L2-13-080U (2104260081
  • 2104260083
  • 2104260082
  • 2104260085
  • 2104260084
  • 2104260087)
  • c. GTIN Number: 00843576152007
  • Catalog Number: 28-L2-15-080U
  • Lot Number: 2104120114
  • d. GTIN Number: 00843576152038
  • Catalog Number (Lot Number): 28-L2-24-080U (2104230422
  • 2104230421)
  • e. GTIN Number: 00843576152076
  • Catalog Number (Lot Number): 28-L2-15-100U (2104170055
  • 2104170053)
  • f. GTIN Number: 00843576152083
  • Catalog Number (Lot Number): 28-L2-17-100U (2104230448

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

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