Penumbra System PST2Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00814548012025), received between Aug 28, 2015 and Nov 3, 2021 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2021Fracture; Suction Failure; Fracture; Suction Failure

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING PENUMBRA SYSTEM MAX ASPIRATION TUBING (TUBING). DURING THE PROCEDURE, THE TUBING DID NOT ASPIRATE AT ALL AND WAS FOUND TO BE CRACKED. THEREFORE, THE TUBING WAS REMOVED. THE PROCEDURE WAS COMPLETED USING NEW TUBING. THERE WAS NO REPORT OF AN ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12744690 ↗
• MalfunctionSep 7, 2016Misconnection; Device Handling Problem; Misconnection; Device Handling Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE FOR A CEREBRAL INFARCTION IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V (PUMP MAX) AND THE PENUMBRA SYSTEM MAX ASPIRATION TUBING (TUBING). DURING THE PROCEDURE, ALTHOUGH THE PATIENT HAD SLIGHTLY TORTUOUS VESSELS, THE PHYSICIAN WAS ABLE TO APPROACH THE RIGHT MCA WITH A PENUMBRA SYSTEM ACE REPERFUSION CATHETER (ACE). THE PHYSICIAN'S ASSISTANT PREPARED FOR THE PROCEDURE BY CONNECTING THE CLEAN SIDE OF THE TUBING TO THE HUB OF THE ACE AND SETTING UP THE PUMP MAX AND CANISTER FOR ASPIRATION. THE PUMP MAX WAS THEN TURNED ON AND ASPIRATION WAS INITIATED. HOWEVER, AFTER WAITING ABOUT NINETY SECONDS, THE PHYSICIAN NOTICED A GRADUAL BACK FLOW OF BLOOD INTO THE PUMP MAX AND THEN NOTICED THAT THE ASSISTANT HAD INAPPROPRIATELY CONNECTED THE BACKSIDE END OF THE TUBING BY MISTAKE. THEREFORE, THE PUMP MAX WAS IMMEDIATELY TURNED OFF AND THE DEVICES WERE RECONNECTED APPROPRIATELY. THE PHYSICIAN THEN RE-INITIATED ASPIRATION AND NOTICED THAT THE ASPIRATION PRESSURE WAS NORMAL. ADDITIONALLY, THERE WAS NO LONGER A BACK FLOW OF BLOOD INTO THE PUMP MAX. THEREAFTER, THE PROCEDURE WAS COMPLETED USING THE SAME PE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5934636 ↗
• MalfunctionAug 2, 2016Device Handling Problem; Device Handling Problem

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL TECHNICIAN INADVERTENTLY DROPPED AN ASPIRATION TUBING ONTO THE FLOOR UPON REMOVING IT FROM THE PACKAGING. THE ASPIRATION TUBING DROPPED PRIOR TO USE AND THEREFORE, WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ASPIRATION TUBING.

  Patient problems: No Patient Involvement

  MAUDE report 5841017 ↗
• MalfunctionApr 29, 2016Hole In Material; Device Damaged Prior to Use; Out-Of-Box Failure; Hole In Material; Device Damaged Prior to Use; Out-Of-Box Failure

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE PHYSICIAN NOTICED THAT THE PENUMBRA SYSTEM MAX ASPIRATION TUBING (TUBING) HAD A HOLE AND THEREFORE, SUCTION WAS NOT POSSIBLE. THE DAMAGED TUBING WAS FOUND PRIOR TO USE AND WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW ASPIRATION TUBING.

  Patient problems: No Patient Involvement

  MAUDE report 5621688 ↗
• MalfunctionFeb 8, 2016Occlusion Within Device; Out-Of-Box Failure; Aspiration Issue; Device Operational Issue; Occlusion Within Device; Out-Of-Box Failure; Aspiration Issue; Device Operational Issue

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE HOSPITAL STAFF NOTICED THAT THE PENUMBRA SYSTEM MAX ASPIRATION TUBING (TUBING) WAS OCCLUDED AND DID NOT ASPIRATE. THE DEFECTIVE TUBING WAS FOUND PRIOR TO USE AND WAS NOT USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW TUBING.

  Patient problems: No Patient Involvement

  MAUDE report 5417563 ↗
• MalfunctionDec 15, 2015Adverse Event Without Identified Device or Use Problem

  DURING PREPARATION FOR A THROMBECTOMY PROCEDURE, THE TECHNOLOGIST HAD DIFFICULTY LOCATING THE PENUMBRA ASPIRATION TUBING (TUBING) BECAUSE THE PACKAGING OF THE TUBING LOOKED SIMILAR TO THE PACKAGING OF OTHER PENUMBRA DEVICES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY MANUAL ASPIRATION USING A PENUMBRA SYSTEM ACE 64 REPERFUSION CATHETER, A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER AND A SYRINGE.

  Patient problems: No Patient Involvement

  MAUDE report 5298134 ↗
• MalfunctionOct 29, 2015Use of Device Problem; Connection Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE FOR ACUTE-STAGE CEREBRAL INFARCTION USING A PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 (PUMP MAX) AND A PENUMBRA SYSTEM MAX ASPIRATION TUBING (TUBING). DURING PREPARATION FOR THE PROCEDURE, THE NURSE MISTAKENLY CONNECTED THE BLUE END TERMINAL OF THE TUBING DIRECTLY TO THE SUCTION PORT OF THE PUMP MAX. DURING THE PROCEDURE, THE PHYSICIAN BEGAN ASPIRATING THE THROMBUS AND NOTICED THE PUMP MAX WAS NOT CONNECTED PROPERLY. THE PHYSICIAN CORRECTLY RECONNECTED THE TUBING AND THE PUMP MAX BUT THE NEGATIVE PRESSURE DID NOT GO DOWN. THE PROCEDURE CONTINUED USING A SYRINGE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5187565 ↗
• MalfunctionAug 28, 2015Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE USING A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAX). UPON REMOVAL FROM THE PACKAGING, A PENUMBRA SYSTEM MAX ASPIRATION TUBING WAS FOUND INSIDE THE BOX LABELLED FOR A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER. THE PROCEDURE CONTINUED USING A NEW 3MAX CATHETER AND THE ASPIRATION TUBING WAS SAVED FOR USE AT A LATER DATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5040340 ↗