CONMED 0037860Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10653405000624), received between Apr 20, 2016 and Nov 18, 2022 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE,0037860, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15824246 ↗
• MalfunctionMay 26, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0037860, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14515936 ↗
• MalfunctionAug 30, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0037860, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12387795 ↗
• MalfunctionAug 30, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0037860, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12385848 ↗
• MalfunctionAug 30, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, CATALOG # 0037860, LOT 202002124, FOR A POSSIBLE BREACH OF STERILITY DUE TO AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH ANY PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION IN (B)(6). THE COMPLETION OF THE DEVICE EVALUATION CONFIRMED AN INSUFFICIENT HEATSEAL; THEREFORE, THIS COMPLAINT MEETS THE CRITERIA FOR A REPORTABLE EVENT. DUE TO THE BREACH IN STERILITY, THIS REPORT IS BEING RAISED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12385426 ↗
• MalfunctionOct 29, 2018Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, (B)(4), ¼"X6' W/M&F CO (SURGICAL TUBING) LOT 201708084 FOR A TEAR IN THE STERILE POUCH/BLISTER PACK. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. DUE TO THE BREACH IN STERILITY, THIS COMPLAINT MEETS THE CRITERIA FOR A REPORTABLE EVENT. THIS REPORT IS BEING RAISED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE .

  Patient problems: No Patient Involvement

  MAUDE report 8016614 ↗
• MalfunctionJun 20, 2018Delivered as Unsterile Product; Delivered as Unsterile Product

  THE DISTRIBUTOR IN (B)(6) REJECTED ONE 0037860, 1/4"(6.4MM)X6"(1.8M) W/M&F CO, DEVICE DUE TO AN "INSUFFICIENT HEATSEAL". IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION PRIOR TO DISTRIBUTION TO AN END-USER. THE REPORT IS RAISED ON THE BASIS OF A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Patient Involvement

  MAUDE report 7620306 ↗
• MalfunctionMay 7, 2018Delivered as Unsterile Product; Delivered as Unsterile Product

  THE DISTRIBUTOR IN (B)(6) REPORTED A "TEAR" ON THE STERILE POUCH OF THIS 0037860, SURGICAL TUBING. THERE WAS NO PATIENT INVOLVEMENT AS THIS DEFECT WAS DISCOVERED DURING INCOMING INSPECTION. THIS REPORT IS RAISED ON THE BASIS OF A MALFUNCTION DUE TO A STERILITY BREACH FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 7490645 ↗
• MalfunctionFeb 22, 2018Packaging Problem; Packaging Problem

  THE DISTRIBUTOR IN (B)(6) REJECTED ONE 0037860 SURGICAL TUBING DUE TO AN "INSUFFICIENT HEATSEAL". IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION PRIOR TO DISTRIBUTION TO AN END-USER. THE REPORT IS RAISED ON THE BASIS OF A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: No Patient Involvement

  MAUDE report 7288861 ↗
• MalfunctionApr 4, 2017Unsealed Device Packaging; Unsealed Device Packaging

  THE DISTRIBUTOR IN (B)(6) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, FOUR (4) PACKAGES CONTAINING ONE (1) EACH 1/4" X 6' SUCTION TUBING WERE DISCOVERED WITH "INSUFFICIENT HEAT SEAL." IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT WITH THIS REPORTED PROBLEM, AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION AT THE DISTRIBUTOR FACILITY PRIOR TO DISTRIBUTION TO AN END-USER.

  Patient problems: Not Applicable

  MAUDE report 6457119 ↗
• MalfunctionMar 30, 2017Device Packaging Compromised; Device Packaging Compromised

  AS REPORTED BY THE DISTRIBUTOR IN (B)(4) , EIGHT (8) 0037860 1/4" X 6' SUCTION TUBING PACKAGES WERE DISCOVERED TO HAVE AN "INSUFFICIENT HEATSEAL OR BLISTER PACK." THERE WAS NO PATIENT INVOLVEMENT IN THIS REPORTED PROBLEM, AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION AT THE DISTRIBUTOR FACILITY PRIOR TO DISTRIBUTION TO AN END-USER. THIS REPORT IS BEING FILED BASED ON THE POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: Not Applicable

  MAUDE report 6446485 ↗
• MalfunctionMar 21, 2017Unsealed Device Packaging; Unsealed Device Packaging

  THE DISTRIBUTOR IN (B)(4) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, ONE (1) PACKAGE CONTAINING ONE (1) EACH 1/4" X 6' SUCTION TUBING WAS DISCOVERED WITH "INSUFFICIENT HEAT SEAL." IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT WITH THIS REPORTED PROBLEM, AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION AT THE DISTRIBUTOR FACILITY PRIOR TO DISTRIBUTION TO AN END-USER.

  Patient problems: Not Applicable

  MAUDE report 6421558 ↗
• MalfunctionDec 20, 2016Unsealed Device Packaging; Unsealed Device Packaging

  THE DISTRIBUTOR IN (B)(4) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, SIX (6) PACKAGES CONTAINING ONE (1) EACH 1/4" X 6' SUCTION TUBING WERE DISCOVERED WITH "INSUFFICIENT HEAT SEAL." IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT WITH THIS REPORTED PROBLEM, AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION AT THE DISTRIBUTOR FACILITY PRIOR TO DISTRIBUTION TO AN END-USER.

  Patient problems: Not Applicable

  MAUDE report 6192092 ↗
• MalfunctionNov 11, 2016Unsealed Device Packaging; Unsealed Device Packaging; Device Operates Differently Than Expected

  THE DISTRIBUTOR IN (B)(6) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, 4 PACKAGES CONTAINING 1/4" X 6' SUCTION TUBING WAS DISCOVERED WITH "INSUFFICIENT HEAT SEAL." THERE WAS NO PATIENT INVOLVEMENT WITH THIS REPORTED PROBLEM, AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION AT THE DISTRIBUTOR FACILITY PRIOR TO DISTRIBUTION TO THE END-USER. THESE DEVICES WERE MANUFACTURED 21-DEC-2015. OF THE LOT CONTAINING 4,800 UNITS THERE WERE NO OTHER SIMILAR COMPLAINTS RECEIVED FOR THIS ITEM AND LOT NUMBER COMBINATION. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT HAS VERIFIED THAT THE DEVICES WERE PRODUCED ACCORDING TO CURRENT AND APPROVED PROCEDURES AND MATERIAL SPECIFICATIONS. NON-CONFORMANCES REGARDING THE PRODUCT'S IDENTITY, QUALITY, SAFETY AND EFFECTIVENESS OR PERFORMANCE WERE NOT IDENTIFIED DURING MANUFACTURE. A 2-YEAR REVIEW OF PRODUCT HISTORY FOR THIS DEVICE FAMILY REVEALED 49 COMPLAINTS INVOLVING 78 CONFIRMED DEVICES FOR THIS SIMILAR COMPLAINT "INSUFFICIENT HEAT SEAL." DURING THIS SAME 2-YEAR TIME FRAME, OVER 13,196,585 UNITS WERE SOLD WORLDWIDE, MAKING THIS OCCURRENCE RATE FOR THIS FAILURE 0.0005 PERCENT. AS OF THIS FILING, THE DEVICE HAS NOT BEEN R

  Patient problems: No Patient Involvement; Not Applicable

  MAUDE report 6095914 ↗
• MalfunctionOct 11, 2016Device Packaging Compromised

  THE DISTRIBUTOR IN (B)(4) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, 5 PACKAGES CONTAINING 1/4" X 6' SUCTION TUBING WAS DISCOVERED WITH "INSUFFICIENT HEAT SEAL." THERE WAS NO PATIENT INVOLVEMENT WITH THIS REPORTED PROBLEM, AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION AT THE DISTRIBUTOR FACILITY PRIOR TO DISTRIBUTION TO AN END-USER.

  Patient problems: No Patient Involvement

  MAUDE report 6016895 ↗
• MalfunctionOct 10, 2016Packaging Problem

  THE DISTRIBUTOR IN (B)(4) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, 1 PACKAGE CONTAINING 1/4" X 6' SUCTION TUBING WAS DISCOVERED WITH "INSUFFICIENT HEAT SEAL." THERE WAS NO PATIENT INVOLVEMENT WITH THIS REPORTED PROBLEM, AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION AT THE DISTRIBUTOR FACILITY PRIOR TO DISTRIBUTION TO AN END-USER.

  Patient problems: No Patient Involvement

  MAUDE report 6015314 ↗
• MalfunctionJun 28, 2016Device Packaging Compromised

  THE DISTRIBUTOR IN (B)(4) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, FOUR (4) PACKAGES CONTAINING 1/4" X 6' SUCTION TUBING WERE DISCOVERED WITH "INSUFFICIENT HEAT SEAL". ALL FOUR (4) OF THE RETURNED PACKAGES EXHIBITED PARTIAL SEAL DISRUPTION IN THE FINAL MANUFACTURING SEALS. IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT WITH THIS REPORTED PROBLEM, AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION AT THE DISTRIBUTOR FACILITY PRIOR TO DISTRIBUTION TO AN END-USER.

  Patient problems: No Patient Involvement

  MAUDE report 5756079 ↗
• MalfunctionJun 7, 2016Device Packaging Compromised

  THE DISTRIBUTOR IN (B)(6) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, SEVEN (7) PACKAGES CONTAINING 1/4" X 6' SUCTION TUBING WERE DISCOVERED WITH "INSUFFICIENT HEAT SEAL". ALL SEVEN (7) OF THE RETURNED PACKAGES EXHIBITED PARTIAL SEAL DISRUPTION IN THE FINAL MANUFACTURING SEALS. IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT WITH THIS REPORTED PROBLEM, AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION AT THE DISTRIBUTOR FACILITY PRIOR TO DISTRIBUTION TO AN END-USER.

  Patient problems: No Patient Involvement

  MAUDE report 5703281 ↗
• MalfunctionMay 25, 2016Device Packaging Compromised

  THE DISTRIBUTOR IN (B)(6) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, THREE (3) PACKAGES CONTAINING 1/4" X 6' SUCTION TUBING WERE DISCOVERED WITH "INSUFFICIENT HEAT SEAL". ALL THREE (3) OF THE RETURNED PACKAGES EXHIBITED PARTIAL SEAL DISRUPTION IN THE FINAL MANUFACTURING SEALS. IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT WITH THIS REPORTED PROBLEM, AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION AT THE DISTRIBUTOR FACILITY PRIOR TO DISTRIBUTION TO AN END-USER.

  Patient problems: No Patient Involvement

  MAUDE report 5678458 ↗
• MalfunctionApr 20, 2016Device Packaging Compromised

  THE DISTRIBUTOR IN (B)(6) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, ONE (1) PACKAGE CONTAINING 1/4" X 6' SUCTION TUBING WAS DISCOVERED WITH "INSUFFICIENT HEAT SEAL". THE RETURNED PACKAGE EXHIBITED FULL OPEN SEAL DISRUPTION IN THE FINAL MANUFACTURING SEALS. IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT WITH THIS REPORTED PROBLEM, AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION AT THE DISTRIBUTOR FACILITY PRIOR TO DISTRIBUTION TO AN END-USER.

  Patient problems: No Patient Involvement

  MAUDE report 5587953 ↗