POOLE 0035040Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10653405000389), received between Oct 10, 2016 and Mar 12, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (9 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2026Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0035040, 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 24581006 ↗
• MalfunctionSep 12, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0035040, 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 23037563 ↗
• MalfunctionMar 17, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  UPDATE 19FEB25: THE DEVICE WAS RETURNED AND EVALUATED. THE COMPLETION OF THE DEVICE EVALUATION CONFIRMED AN INSUFFICIENT HEATSEAL; THEREFORE, THIS COMPLAINT HAS BEEN REASSESSED AND MEETS THE CRITERIA FOR A REPORTABLE EVENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE. THE DISTRIBUTOR REPORTED THAT THE 0035040 DEVICE HAD AN INSUFFICIENT HEATSEAL FOUND DURING INCOMING INSPECTION. NO PATIENT INVOLVEMENT OCCURRED. THE SHIPMENT ASSOCIATED WITH THE RGA FOR THIS DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION AND IT HAS NOT BEEN CONFIRMED THAT AN INSUFFICIENT HEATSEAL CAUSING A STERILITY BREACH HAS OCCURRED. BASED ON THE INFORMATION AVAILABLE, AND THE DECISION TREE RESULTS, THIS COMPLAINT DOES NOT MEET THE DEFINITION OF A REPORTABLE EVENT. UPON THE RECEIPT OF THE DEVICE, AN EVALUATION WILL BE CONDUCTED AND IF A BREACH OF STERILITY IS CONFIRMED THE REPORTING DECISION WILL BE REASSESSED AT THAT TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21617297 ↗
• MalfunctionJan 17, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0035040, 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 21178367 ↗
• MalfunctionSep 15, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0035040, 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 17754231 ↗
• MalfunctionJan 26, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0035040, 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 16247464 ↗
• MalfunctionJan 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE DEVICE, 0035040, POOLE SUCTION INSTRUMENT (50/CS), WAS BEING USED DURING AN EMERGENCY LAPAROTOMY PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED, ¿WE EXPERIENCED SOME ISSUES WITH 3 OF THIS PRODUCT OVERNIGHT DURING AN EMERGENCY LAPAROTOMY. TWO (2) CAME APART WITHIN THE OPEN ABDOMEN, AND A THIRD BROKE DURING ASSEMBLY PRIOR TO USE. I HAVE BEEN ABLE TO CONFIRM THESE ARE ALL FROM THE SAME BATCH/LOT NUMBER.¿. THE PROCEDURE WAS REPORTED AS HAVING BEEN COMPLETED WITHOUT ANY INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE COMPONENTS WERE RETRIEVED FROM THE PATIENT BY HAND CAUSING A 5¿10-MINUTE DELAY. IT WAS ADVISED THAT THE PATIENT IS ¿ABSOLUTELY FINE¿. 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 16120164 ↗
• MalfunctionJul 25, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0035040, 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 15092544 ↗
• MalfunctionMar 8, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0035040, 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 13695097 ↗
• MalfunctionFeb 18, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0035040, 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 13558172 ↗
• MalfunctionMay 15, 2017Device Packaging Compromised; Device Packaging Compromised

  AS REPORTED BY THE DISTRIBUTOR IN (B)(6), ONE (1) POOLE SUCTION INSTRUMENT WITH REMOVABLE SHEATH WAS 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 6566605 ↗
• MalfunctionApr 26, 2017Unsealed Device Packaging; Unsealed Device Packaging

  THE DISTRIBUTOR IN (B)(6) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, TWO (2) PACKAGES, CONTAINING ONE EACH POOLE WITH REMOVABLE SHEATH, WERE DISCOVERED WITH "THE SEAL OF THE STERILE POUCH WAS BREACHED." 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. THIS REPORT IS BEING FILED BASED ON THE POTENTIAL FOR INJURY WITH RECURRENCE.

  Patient problems: Not Applicable

  MAUDE report 6523353 ↗
• MalfunctionApr 4, 2017Device Packaging Compromised; Device Packaging Compromised

  AS REPORTED BY THE DISTRIBUTOR IN (B)(4), ONE (1) POOLE SUCTION INSTRUMENT WAS 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 6457087 ↗
• MalfunctionMar 21, 2017Unsealed Device Packaging; Unsealed Device Packaging

  AS REPORTED BY THE DISTRIBUTOR IN (B)(4), DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, 1 PACKAGE CONTAINING A POOLE SUCTION INSTRUMENT WAS DISCOVERED TO HAVE "INSUFFICIENT HEATSEAL." 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 6421917 ↗
• MalfunctionOct 10, 2016Device Damaged Prior to Use; Device Packaging Compromised; Packaging Problem

  THE DISTRIBUTOR IN (B)(4) REPORTED THAT DURING RECEIVING AND INSPECTION OF INCOMING PRODUCTS, 2 PACKAGES, EACH CONTAINING ONE 10 FRENCH FRAZIER SUCTION INSTRUMENT, 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 6015323 ↗