QuikClot 0459Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841495104596), received between Nov 18, 2022 and Jul 2, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Handling Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K123387); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT: QUICK CLOT WAS LEFT IN PATIENT FOR A YEAR AND WAS FOUND ON MRI AND MAMMOGRAM. PROVIDER WAS CALLING ABOUT INFORMATION WE HAVE ON LEAVING THE PRODUCT INTERNAL IN A PATIENT FOR EXTENDED AMOUNT OF TIME. I INFORMED HER OF THE IFU WE FOLLOW AND PRODUCT GUIDELINES WE TEACH. FOLLOW UP WAS PROVIDED FROM DAN SMITH AND PROVIDER WAS ADVISED TO REMOVE THE PRODUCT SINCE WE DONT HAVE ANY LITERATURE TO SUPPORT LONG TERM PLACEMENT OF THIS PRODUCT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19653746 ↗
• InjuryNov 18, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT A 4X4 QUIK CLOT WAS LEFT BEHIND IN PATIENT AND CLOSED DURING AN ORTHO SPINE CASE ON (B)(6) 2022. ADDITIONAL INFORMATION: IT WAS REPORTED THAT 2-3 WEEKS AFTER THE INITIAL SURGERY THE PATIENT HAD A POST-OP VISIT AND IT WAS DISCOVERED THAT THE SPONGE HAD BEEN LEFT INSIDE THE PATIENT. NO PHYSICAL SIGNS OR SYMPTOMS WERE DESCRIBED IN THIS REPORT. THE PATIENT HAD AN OVERNIGHT HOSPITAL STAY AFTER THE SURGERY TO REMOVE THE SPONGE. THE PATIENT'S CURRENT CONDITION POST-OP WAS REPORTED AS "NO ISSUES HAVE BEEN REPORTED" AND IT IS UNKNOWN IF ANY ANTIBIOTICS OR OTHER TREATMENT WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15828378 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123387. One submission often covers many models, so check the product and lot details in each record.

• Z-0925-2018 · Nov 17, 2017 · Terminated
  QuikClot TraumaPad, Part# 460 a topical dressing for local management of bleeding wounds such as cuts, lacerations, and abrasions. It may also be used for temporary treatment of se
• Z-2612-2017 · May 17, 2017 · Terminated
  QuikClot TraumaPad, , sterile, soft, white, X-ray detectable hemostatic dressing Part Number 460 Manufactured by Z-Medica, LLC 4 Fairfield Boulevard, Wallingford, CT 06492 USA For