Progel PGPS002Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00801741010026), received between Jul 25, 2017 and Aug 6, 2026 — classified as 2 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Break” (28 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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50160183 ↗
• MalfunctionJul 30, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50085766 ↗
• MalfunctionDec 16, 2025Break; Break

  AS REPORTED, DURING A LEFT VIDEO ASSISTED THORACIC SURGERY, THE GLASS VIAL OF PROGEL PLEURAL AIR LEAK SEALANT SHATTERED WHEN THE PLUNGER WAS DEPRESSED TO LOCK THE VIALS IN PLACE. NO EXCESSIVE FORCE WAS APPLIED. THE PROGEL PRODUCT WAS STORED AT 2 TO 8 DEGREE CELSIUS AND WAS PREPARED BY THE SCRUB NURSE, WHO IS FAMILIAR WITH ITS USE. ANOTHER PROGEL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT OR USER INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817281 ↗
• MalfunctionAug 8, 2025Break; Break

  AS REPORTED, DURING A ROBOTIC WEDGE RESECTION PROCEDURE THE PROGEL PLEURAL AIR LEAK SEALANT GLASS VIAL CRACKED PRIOR TO APPLICATION. THE PRODUCT WAS USED WITHIN 20 MINUTES OF MIXING THE PRODUCT. THE PRODUCT WAS DISCARDEDTHE SURGEON AND OR STAFF ARE FAMILIAR WITH USING THE PROGEL PRODUCT AND DID NOT USE EXCESSIVE FORCE WHEN APPLYING THE PRODUCT. THERE WAS NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22748973 ↗
• MalfunctionMay 23, 2025Break; Break

  AS REPORTED, OR TECH PUSHED THE GLASS CARTRIDGES INTO DUAL-BARREL APPLICATOR HOUSING USING THE PUSH RODS BY USING EXCESSIVE FORCE WHEN PREPARING THE PROGEL FOR USE INSTEAD OF GENTLY PRESSING THEM INTO THE APPLICATOR. THE SURGEON WENT TO TRY AND USE IT, AND THE GLASS CARTRIDGE WAS BREAKING. IT WAS REPORTED THAT THE NEW PRODUCT WAS USED TO COMPLETE THE CASE AND THERE WAS NO PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077560 ↗
• MalfunctionMay 7, 2025Break; Break

  AS REPORTED, DURING A THORACOTOMY PROCEDURE ONE OF THE GLASS VIALS TO BREAK WITHIN THE PROGEL APPLICATOR. THE PRODUCT HAD BEEN MIXED AND THE APPLICATOR ASSEMBLED, BUT THE PROGEL HAD HARDENED IN THE TIP AND SEEMS THE APPLICATOR WAS NOT WIPED CLEAN BEFORE ATTACHING THE TIP. IT WAS REPORTED THAT THE SURGEON ASSISTANT APPLIED EXCESSIVE FORCE TO THE TO EXPEL THE PRODUCT AFTER IT HARDENED, CAUSING THE GLASS VIAL TO BREAK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977202 ↗
• InjuryJan 22, 2025Obstruction of Flow; Obstruction of Flow

  AS REPORTED, THE SURGEON RESPONDED TO THE SALES REP'S FOLLOW UP ON HER EXPERIENCE USING THE PRODUCT PROGEL. THE SURGEON EXPLAINED THAT DURING THE SUMMER IN 2024 AFTER USE OF PROGEL SHE HAD A PATIENT WHO POST OPERATIVELY EXPERIENCED SUBCUTANEOUS EMPHYSEMA. THE SURGEON DID NOT PROVIDE ANY MORE DETAIL ABOUT THE SPECIFIC CASE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pulmonary Emphysema

  MAUDE report 21211619 ↗
• MalfunctionSep 20, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, UPON OPENING THE PROGEL UNIT FOR A CASE, IT WAS DISCOVERED THAT THERE WAS WHAT APPEARED TO BE MOLD INSIDE THE CONTAINER AND THE OUTSIDE PACKAGE HAD SOME OBVIOUS WATER SPOTS. IT WAS REPORTED THAT THE PRODUCT WAS STORED IN REFRIGERATOR WITH TEMPERATURE BETWEEN 36°F AND 46°F FOR SEVERAL MONTHS. IT WAS ALSO REPORTED THAT SOME CONDENSATION IN THE BACK OF REFRIGERATOR WAS NOTED AND HAD SOME WATER PUDDLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268327 ↗
• MalfunctionJul 23, 2024Break; Break

  AS REPORTED, DURING LOBECTOMY PROCEDURE, THE PROGEL PUSH ROD LODGED INTO THE HSA VIAL, WHICH LED TO BREAK AND THE FLUID LEAKED OUT OF THE BACK. IT WAS REPORTED THAT THE GLASS WAS CRACKED AND ANOTHER NEW DEVICE WAS USED TO COMPLETE. PROGEL PRODUCT WAS STORED IN THE FRIDGE BETWEEN 2-8 DEGREES CELSIUS. THE PRODUCT WAS USED WITHIN 20 MINUTES OF MIXING PEG AND STERILE WATER AND THE SURGEON DID NOT USE EXCESSIVE FORCE WHEN APPLYING PRODUCT. THERE WAS A DELAY IN THE SURGERY AND NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19807813 ↗
• MalfunctionDec 20, 2023Break; Break

  IT WAS REPORTED THAT AFTER A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) THE USER ATTEMPTED TO REMOVE THE PUSH ROD FROM THE APPLICATOR AFTER ATTEMPTED USE. THIS RESULTED A GLASS VIAL BREAK AND PUSH ROD BECOMING TWISTED. THE PRODUCT WAS USED WITHIN 20 MINUTES OF MIXING PEG AND STERILE WATER AND THE VIAL DID NOT BREAK WHEN ATTEMPTING TO USE THE DEVICE. ANOTHER PROGEL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18364361 ↗
• MalfunctionJul 31, 2023Break; Break

  AS REPORTED, DURING A ROBOTIC LUNG RESECTION PROCEDURE THE PROGEL WAS USED. IT WAS REPORTED THAT THE PROGEL WAS MIXED FOLLOWING THE MIXING PARAMETERS AND TIMELINE WITH PROPER IFU PROTOCOLS. IT WAS REPORTED THAT WHEN THE PHYSICIAN ASSISTANT WENT TO APPLY THE PROGEL, AND PRESSED ON THE LOCKING PUSH ROD, THE CARTRIDGES SHATTERED. IT WAS ALSO REPORTED THAT NO GLASS PIECES CAME OUT OF THE APPLICATOR HOUSING. ANOTHER PROGEL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17424152 ↗
• MalfunctionJun 21, 2023Break; Break

  AS REPORTED, DURING A LOBECTOMY PROCEDURE THE PROGEL SEALANT WAS PREPPED AS DIRECTED AND USED WITHIN 20 MINUTES, HOWEVER, IT HARDENED UP BEFORE SPRAYED AND WOULD NOT RELEASE THE PRODUCT. AS REPORTED, THE PROCEDURE WAS COMPLETED USING ANOTHER PROGEL. SAMPLE EVALUATION FOUND BROKEN GLASS VIAL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17172762 ↗
• MalfunctionOct 12, 2022Break; Break

  AS REPORTED, DURING A VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) WEDGE PROCEDURE WITH PLEURODESIS ON (B)(6) 2022, WHILE APPLYING THE PROGEL ONE OF THE VIALS CRACKED. AS REPORTED EXCESSIVE FORCE WAS NOT USED AND THE PRODUCT WAS ATTEMPTED TO BE USED WITHIN 20 MINUTES OF DISSOLVING THE PEG PER THE INSTRUCTIONS-FOR-USE. IT WAS REPORTED THE PRODUCT WAS PROPERLY STORED BETWEEN 2-8 DEGREES CENTIGRADE. AS REPORTED THE OR STAFF WAS NOT FAMILIAR WITH THE PROGEL PRODUCT. THE PROCEDURE WAS COMPLETED WITH ANOTHER KIT AND THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15587271 ↗
• MalfunctionJul 21, 2022Break; Break

  AS REPORTED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, THE BARD/DAVOL PROGEL GLASS VIAL BROKE DURING PREPARATION. IT WAS REPORTED THAT THE BROKEN GLASS VIAL AND APPLICATOR WAS REMOVED AND ANOTHER PROGEL WAS USED TO COMPLETE THE CASE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15076223 ↗
• MalfunctionMay 13, 2022Break; Break

  AS REPORTED, WHILE ASSEMBLING THE BARD/DAVOL PROGEL PLEURAL AIR LEAK SEALANT DURING A PROCEDURE ON (B)(6) 2022, THE LIQUID VIAL BROKE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14401416 ↗
• MalfunctionFeb 24, 2022Break; Break

  AS REPORTED, DURING AN OPEN THORACOTOMY WEDGE RESECTION PROCEDURE ON (B)(6) 2022, WHILE USING THE BARD/DAVOL PROGEL PLEURAL AIR LEAK SEALANT (PALS), THE TIP BECAME CLOGGED AND WAS EXCHANGED. AS REPORTED, WHEN THE SURGEON ATTEMPTED TO SPRAY THE SURGICAL SITE, THE HUMAN SERUM ALBUMIN (HSA) GLASS VIAL SHATTERED WITHIN THE APPLICATOR. THE BROKEN GLASS WAS CONTAINED WITHIN THE APPLICATOR. THE SURGEON WAS ABLE TO COMPLETE THE CASE WITH THE PRODUCT THAT WAS USED. AS REPORTED, THE PRODUCT WAS REFRIGERATED BETWEEN 36-46°F AS RECOMMENDED, WAS ASSEMBLED PROPERLY AND WAS USED WITHIN 20 MINUTES OF MIXING THE PRODUCT. THERE WAS NO REPORTED PATIENT HARM/INJURY AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13590203 ↗
• MalfunctionFeb 2, 2022Break; Break

  AS REPORTED, DURING THE END OF A ROBOTIC CONVERTED TO AN OPEN WEDGE RESECTION PROCEDURE ON (B)(6) 2022, THE HUMAN SERUM ALBUMIN (HSA) VIAL OF THE BARD/DAVOL PROGEL PLEURAL AIR LEAK SEALANT SHATTERED WITHIN THE APPLICATOR DURING APPLICATION OF THE SEALANT. AS REPORTED, THE BREAK OCCURRED WITHIN THE APPLICATOR AND NOT ON THE PATIENT. IT WAS REPORTED THAT THE PRODUCT WAS STORED BETWEEN 36°F-46°F AND WAS USED WITHIN 20 MINUTES OF MIXING THE PRODUCT. AS REPORTED, THE CARDIOTHORACIC SURGEON WAS NOT ABLE TO EFFECTIVELY USE ALL OF THE SEALANT AND THE PROCEDURE WAS COMPLETED USING ANOTHER PROGEL. AS REPORTED, THE SURGEON MAY HAVE BEEN APPLYING TOO MUCH FORCE WHEN THE VIAL BROKE INSIDE THE APPLICATOR. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13423811 ↗
• MalfunctionDec 31, 2021Break; Break

  THE FOLLOWING WAS REPORTED VIA MAUDE EVENT REPORT (MW5105219): "THE PATIENT HAD A RIGHT THORACOTOMY/DECORTICATION SURGERY. THE SURGEON WAS USING SEVERAL OF THE PROGEL SYRINGES DURING THE CASE (PLEURAL AIR LEAK SEALANT). AS HE BEGAN TO INJECT THE PROGEL INTO THE CHEST CAVITY, ONE OF THE SYRINGES BROKE INSIDE THE SYRINGE CHAMBER. HE WAS UNABLE TO GET ANY PROGEL OUT OF THE TIP OF THE SYRINGE AT THIS POINT. A FEW SHARDS FROM THE SYRINGE LANDED ON THE STERILE DRAPE. THE CHEST CAVITY WAS INSPECTED AND NO SYRINGE SHARDS WERE FOUND. THE SYRINGE WAS IMMEDIATELY REMOVED FROM THE FIELD AND STERILITY MAINTAINED. NO HARM CAME TO THE PATIENT. POST-OPERATIVE CHEST X-RAY DOES NOT SHOW FOREIGN BODY IN PATIENT'S CHEST."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13125196 ↗
• MalfunctionNov 9, 2021Break

  THE PATIENT HAD A RIGHT THORACOTOMY/DECORTICATION SURGERY. THE SURGEON WAS USING SEVERAL OF THE PROGEL SYRINGES DURING THE CASE (PLEURAL AIR LEAK SEALANT). AS HE BEGAN TO INJECT THE PROGEL INTO THE CHEST CAVITY, ONE OF THE SYRINGES BROKE INSIDE THE SYRINGE CHAMBER. HE WAS UNABLE TO GET ANY PROGEL OUT OF THE TIP OF THE SYRINGE AT THIS POINT. A FEW SHARDS FROM THE SYRINGE LANDED ON THE STERILE DRAPE. THE CHEST CAVITY WAS INSPECTED AND NO SYRINGE SHARDS WERE FOUND. THE SYRINGE WAS IMMEDIATELY REMOVED FROM THE FIELD AND STERILITY MAINTAINED. NO HARM CAME TO THE PATIENT, POST-OPERATIVE CHEST X-RAY DOES NOT SHOW FOREIGN BODY IN PATIENT'S CHEST. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12786815 ↗
• MalfunctionMar 1, 2021Break; Break

  AS REPORTED ON (B)(6) 2021, THE PROGEL WAS PREPARED AND THE VIALS INSERTED INTO THE APPLICATOR. AT THIS POINT A PIECE OF GLASS WAS OBSERVED ON THE TABLE, WHICH PROMPTED THE TECH TO CHECK THE GLASS VIALS THEY HAD JUST INSERTED INSIDE THE APPLICATOR. IT WAS NOTED THAT ONE OF THE VIALS WAS CHIPPED. ANOTHER PROGEL WAS USED TO COMPLETE THE CASE AND THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11396161 ↗
• MalfunctionJan 13, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED PROCEDURE, THE PROGEL PLEURAL AIR LEAK SEALANT PLUNGER WAS BENT AND THE BARREL BROKE AND THE PRODUCT WAS NOT USED. THE CASE WAS COMPLETED WITH A NEW PROGEL KIT. NO PATIENT SAFETY WAS COMPROMISED. AS REPORTED, PER THE CUSTOMER CONTACT, THE PROGEL WAS NOT ASSEMBLED, THE PLUNGER WAS FULLY ALIGNED; THE TOP OF THE BARREL MAY BE BROKEN AND THE GLASS VIALS WERE NOT BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11162633 ↗
• MalfunctionDec 2, 2020Crack; Crack

  AS REPORTED, DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2020 IT WAS NOTED THAT THE PROGEL KIT HAD A SHATTERED VIAL IN IT. ANOTHER PROGEL KIT WAS USED TO COMPLETE THE PROCEDURE. THE SURGEON IS AN EXPERIENCED USER OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10934795 ↗
• MalfunctionNov 19, 2020Break; Break

  AS REPORTED, DURING A WEDGE RESECTION PROCEDURE ON (B)(6) 2020, THE OR TECH. PREPARED THE PROGEL PER INSTRUCTIONS FOR USE, USING PROPER TECHNIQUE. RESISTANCE WAS NOT FELT WHEN PURGING THE AIR PRIOR TO USE. THE PREPARED PROGEL APPLICATOR WAS HANDED TO THE SURGEON. AS THE SURGEON WAS ADVANCING THE PUSH ROD, IT WAS IMMEDIATELY NOTED THAT BOTH THE PEG (POLYETHYLENE GLYCOL) AND HSA (HUMAN SERUM ALBUMIN) VIALS WERE CRACKED. THE SURGEON DID NOT USE THE PROGEL PRODUCT AND A NEW KIT WAS PREPARED AND USED FROM A DIFFERENT LOT WITHOUT ANY ISSUE. AS REPORTED, THE OR STAFF AND SURGEON ARE EXPERIENCED IN USING PROGEL, ALL THE PRODUCTS ARE STORED IN THE REFRIGERATOR BETWEEN 36-46 DEGREE FAHRENHEIT AS RECOMMENDED. AS REPORTED, THE SURGEON DID NOT USE ANY EXCESSIVE FORCE WHEN APPLYING THE PROGEL. IT WAS ALSO REPORTED THAT SOME PIECES OF GLASS FROM THE PRODUCT HAD BEEN REMOVED AT THAT TIME AND DISCARDED. AS REPORTED, THERE WAS NO PATIENT HARM/INJURY AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10869121 ↗
• MalfunctionNov 19, 2020Break; Break

  AS REPORTED, DURING A WEDGE RESECTION PROCEDURE ON (B)(6) 2020, THE OPERATING ROOM TECH. PREPARED THE PROGEL PER INSTRUCTIONS FOR USE, USING PROPER TECHNIQUE. RESISTANCE WAS NOT FELT WHEN PURGING THE AIR PRIOR TO USE. THE PREPARED PROGEL APPLICATOR WAS HANDED TO THE SURGEON. AS THE SURGEON WAS ADVANCING THE PUSH ROD, IT WAS IMMEDIATELY NOTED THAT BOTH THE PEG (POLYETHYLENE GLYCOL) AND HSA (HUMAN SERUM ALBUMIN) VIALS WERE CRACKED. THE SURGEON DID NOT USE THE PROGEL PRODUCT AND A NEW KIT WAS PREPARED AND USED FROM A DIFFERENT LOT WITHOUT ANY ISSUE. AS REPORTED, THE OR STAFF AND SURGEON ARE EXPERIENCED IN USING PROGEL, ALL THE PRODUCTS ARE STORED IN THE REFRIGERATOR BETWEEN 36-46 DEGREE FAHRENHEIT AS RECOMMENDED. AS REPORTED, THE SURGEON DID NOT USE ANY EXCESSIVE FORCE WHEN APPLYING THE PROGEL. IT WAS ALSO REPORTED THAT SOME PIECES OF GLASS FROM THE PRODUCT HAD BEEN REMOVED AT THAT TIME AND DISCARDED. AS REPORTED, THERE WAS NO PATIENT HARM/INJURY AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10869118 ↗
• MalfunctionDec 5, 2019Break; Break

  IT WAS REPORTED THAT THE USER PREPARED THE PROGEL PRODUCT AND DURING USE, NOTED THE CARTRIDGE WAS BROKEN. THERE WAS NO CONCERN FOR ANY OF THE PIECES OF THE DEVICE TO HAVE COME INTO CONTACT WITH THE PATIENT AND THERE WAS NO PATIENT OR USER INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9418835 ↗