ClearTract 211610SPTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850041415154), received between Dec 15, 2025 and Dec 15, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (1 report).

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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 15, 2025Partial Blockage; Partial Blockage

  ON (B)(6) 2023, A PATIENT PARTICIPATING IN A CLINICAL STUDY UNDERWENT IMPLANTATION OF A SILQ CLEARTRACT CATHETER. THE SAME DAY, THE SITE RECEIVED A CALL FROM THE PATIENT STATING THAT THE CATHETER WAS NOT WORKING (IN RETENTION). THE PATIENT ALSO REPORTED ABDOMINAL PAIN AND CONSTIPATION. ON (B)(6) 2023, THE PATIENT RETURNED TO THE CLINIC; CATHETER BLOCKAGE WAS OBSERVED AND THE CATHETER WAS REMOVED. THE EVENT WAS CONSIDERED RESOLVED UPON CATHETER EXPLANT. THE CATHETER IN QUESTION WAS RETURNED TO SILQ AND WAS EVALUATED BY SILQ REPRESENTATIVES.

  Patient problems: Urinary Retention

  MAUDE report 23811837 ↗
• MalfunctionDec 15, 2025Material Rupture; Material Rupture

  A PATIENT PARTICIPATING IN A CLINICAL STUDY (B)(6) WAS PROVIDED A 2-WAY 100% SILICONE, 16FR X 10ML, CLEARTRACT SPT CATHETER (PRIMARY DI: (B)(4)). THE CATHETER WAS INSERTED WITH NO APPARENT ISSUES BY A NURSE AT (B)(6) ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT RETURNED COMPLAINING OF PAIN AND DISCOMFORT. THE ATTENDING NURSE TRIED TO DEFLATE THE BALLOON TO CHECK THE POSITIONING OF THE CATHETER AND THE BALLOON DID NOT HAVE ANY WATER IN IT. THE NURSE TRIED TO ADD WATER TO THE BALLOON, HOWEVER, ALL OF THE WATER FROM THE BALLOON RAN IMMEDIATELY OUT OF THE URETHRA ALONG THE CATHETER. THE NURSE THEN REMOVED THE CATHETER AND REPLACED WITH A NON-STUDY CATHETER. UPON REMOVAL OF THE SILQ CATHETER, THE NURSE NOTED THAT THE BALLOON WAS RUPTURED. (B)(6), (B)(6) COORDINATOR, REPORTED THE EVENT TO SILQ TECHNOLOGIES. SILQ TECHNOLOGIES MADE CONTACT WITH THE NURSE AND PHYSICIAN WHO INDICATED THAT THERE WAS NO INJURY TO THE PATIENT AND NO PAIN ASSOCIATED DIRECTLY WITH THE CATHETER. A SILQ EMPLOYEE VISITED THE FACILITY ON (B)(6) 2023 TO RETRIEVE THE CATHETER. FURTHER ANALYSIS CONFIRMED THE CATHETER BALLOON HAD RUPTURED, ALTHOUGH A ROOT CAUSE OF THE RUPTURE COULD NOT BE ESTABLISHED.

  Patient problems: Urinary Retention

  MAUDE report 23811813 ↗