Desara TV CAL-DS01TVRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00890594000827), received between Jun 24, 2019 and Jun 24, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PER (B)(4) (VICE PRESIDENT, PORTFOLIO STRATEGY) "DR. (B)(6) REPORTED TO SALES REP THAT HE HAD 3 PATIENTS COME BACK FOR THEIR 6 WEEK CHECK-UP RECENTLY AND ALL 3 HAD MESH EXPOSURE. THEY WERE ALL OPERATED ON THE SAME DAY IN THE SAME OPERATING ROOM AT (B)(6) HOSPITAL AND THIS WAS UNUSUAL. THE PRODUCT USED WAS DESARA TV (CLEAR). SALES REP NOTED THAT THE TV32 INSTRUMENTS AT (B)(6) HAD LOST THEIR CURVE AND SHE IS RETURNING AND REPLACING THEM. THESE SHOULD BE EVALUATED FOR LOT # AND TO UNDERSTAND THE AMOUNT OF DEFORMATION THEY EXPERIENCED AND IF THIS COULD HAVE PLAYED A ROLE. SALES REP DID TALK TO THE ANOTHER PHYSICIAN AT THIS HOSPITAL, DR. (B)(6), AND HE HAS NOT HAD ANY ISSUES WITH HIS PATIENTS. HE SUGGESTED THAT PERHAPS SOMETHING ELSE DIFFERED ON THAT DAY. FOR INSTANCE, DR. (B)(6) USES A HEMOSTATIC AGENT IN THE SULCUS PRIOR TO CLOSING THE INCISION - DID HE USE THIS ON THESE PATIENTS? IF NOT, THIS COULD RESULT IN MORE BLEEDING THAN USUAL AND, IF BELOW THE INCISION LINE, COULD RESULT IN DELAYED TISSUE INGROWTH AND MESH EXTRUSION. THIS IS JUST SPECULATION, BUT IT WAS GOOD TO HEAR THAT DR. (B)(6), USING THE SAME PRODUCT AND INSTRUMENTS, DID NOT HAVE ANY PATIENT ISSUES." S. (B)(4) REQUESTED A

  Patient problems: Erosion

  MAUDE report 8727686 ↗
• InjuryJun 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PER (B)(6) (VICE PRESIDENT, PORTFOLIO STRATEGY) "DOCTOR (B)(6) REPORTED TO SALES REP THAT HE HAD 3 PATIENTS COME BACK FOR THEIR 6 WEEK CHECK-UP RECENTLY AND ALL 3 HAD MESH EXPOSURE. THEY WERE ALL OPERATED ON THE SAME DAY IN THE SAME OPERATION ROOM AT (B)(6) HOSPITAL AND THIS WAS UNUSUAL. THE PRODUCT USED WAS DESARA TV (CLEAR). SALES REP NOTED THAT THE TV32 INSTRUMENTS AT (B)(6) HAD LOST THEIR CURVE AND SHE IS RETURNING AND REPLACING THEM. THESE SHOULD BE EVALUATED FOR LOT # AND TO UNDERSTAND THE AMOUNT OF DEFORMATION THEY EXPERIENCED AND IF THIS COULD HAVE PLAYED A ROLE. SALES REP DID TALK TO THE ANOTHER PHYSICIAN AT THIS HOSPITAL, DOCTOR (B)(6) AND HE HAS NOT HAD ANY ISSUES WITH HIS PATIENTS. HE SUGGESTED THAT PERHAPS SOMETHING ELSE DIFFERED ON THAT DAY. FOR INSTANCE, DOCTOR (B)(6) USES A HEMOSTATIC AGENT IN THE SULCUS PRIOR TO CLOSING THE INCISION - DID HE USE THIS ON THESE PATIENTS? IF NOT, THIS COULD RESULT IN MORE BLEEDING THAN USUAL AND, IF BELOW THE INCISION LINE, COULD RESULT IN DELAYED TISSUE INGROWTH AND MESH EXTRUSION. THIS IS JUST SPECULATION, BUT IT WAS GOOD TO HEAR THAT DOCTOR (B)(6), USING THE SAME PRODUCT AND INSTRUMENTS, DID NOT HAVE ANY PATIENT ISSUES."(B)(6) REQU

  Patient problems: Erosion

  MAUDE report 8727617 ↗
• InjuryJun 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PER (B)(6) (VICE PRESIDENT, PORTFOLIO STRATEGY) "DR. (B)(6) REPORTED TO SALES REP THAT HE HAD 3 PATIENTS COME BACK FOR THEIR 6 WEEK CHECK-UP RECENTLY AND ALL 3 HAD MESH EXPOSURE. THEY WERE ALL OPERATED ON THE SAME DAY IN THE SAME OPERATING ROOM AT (B)(6) HOSPITAL AND THIS WAS UNUSUAL. THE PRODUCT USED WAS DESARA TV (CLEAR). SALES REP NOTED THAT THE TV32 INSTRUMENTS AT (B)(6 AD LOST THEIR CURVE AND SHE IS RETURNING AND REPLACING THEM. THESE SHOULD BE EVALUATED FOR LOT # AND TO UNDERSTAND THE AMOUNT OF DEFORMATION THEY EXPERIENCED AND IF THIS COULD HAVE PLAYED A ROLE. SALES REP DID TALK TO THE ANOTHER PHYSICIAN AT THIS HOSPITAL, DR. (B)(6), AND HE HAS NOT HAD ANY ISSUES WITH HIS PATIENTS. HE SUGGESTED THAT PERHAPS SOMETHING ELSE DIFFERED ON THAT DAY. FOR INSTANCE, DR. (B)(6) USES A HEMOSTATIC AGENT IN THE SULCUS PRIOR TO CLOSING THE INCISION - DID HE USE THIS ON THESE PATIENTS? IF NOT, THIS COULD RESULT IN MORE BLEEDING THAN USUAL AND, IF BELOW THE INCISION LINE, COULD RESULT IN DELAYED TISSUE INGROWTH AND MESH EXTRUSION. THIS IS JUST SPECULATION, BUT IT WAS GOOD TO HEAR THAT DR. (B)(6), USING THE SAME PRODUCT AND INSTRUMENTS, DID NOT HAVE ANY PATIENT ISSUES." (B)(6) REQUESTED ADDITI

  Patient problems: Erosion

  MAUDE report 8727574 ↗