NA IP-37957Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886704044086), received between Oct 2, 2020 and Dec 27, 2021 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (4 reports).

15 other recalls cover devices cleared under the same FDA submission (P800036, P890055); they may or may not involve this specific model.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMBINED PRIMARY RESECTION WITH HEPATIC ARTERY INFUSION PUMP IMPLANTATION IS SAFE FOR UNRESECTABLE COLORECTAL LIVER METASTASES WAS PUBLISHED IN THE JOURNAL OF GASTROINTESTINAL SURGERY AND PUBLISHED ONLINE 24 NOVEMBER 2021. THIS PUBLICATION IS A RETROSPECTIVE STUDY OF 32 PATIENTS WHO UNDERWENT HEPATIC ARTERY INFUSION (HAI) PUMP PLACEMENT FOR TREATMENT COLORECTAL CANCER METASTATIC TO THE LIVER. THE HAI PUMP WAS DESCRIBED AS MEDTRONIC SYNCHROMED II PROGRAMMABLE PUMP SPLICED TO THE CODMAN TAPERED CATHETER. HAI-RELATED COMPLICATIONS THAT WERE PUBLISHED WERE: PUMP POCKET SEROMA (11%), GASTRODUODENAL ARTERY PSEUDOANEURYSM (5%), BILIARY SCLEROSIS (5%), PUMP POCKET HEMATOMA (8%), HEPATIC ARTERIAL DISSECTION (8%), EXTRAHEPATIC PERFUSION (8%), AND PUMP POCKET INFECTION (8%). THE ADVERSE EVENT RELATED TO THE USE OF THE TAPERED CATHETER THAT WAS REPORTED WAS GASTRODUODENAL ARTERY PSEUDOANEURYSM. THE ARTICLE REPORTS THAT "ONE PATIENT IN THE COMBINED GROUP ACCOUNTED FOR BOTH AN EARLY PUMP POCKET SEROMA AND A DELAYED ARTERIAL PSEUDOANEURYSM. THE PSEUDOANEURYSM OCCURRED DURING AN EPISODE OF PANCREATITIS APPROXIMATELY 8 MONTHS AFTER HAI PUMP PLACEMENT AND FOLLOWING DEFINITIVE HEPATIC RESECTION." FOL

  Patient problems: Pseudoaneurysm

  MAUDE report 13087688 ↗
• MalfunctionOct 14, 2020Defective Device; Defective Device

  DURING A HEPATIC ARTERY INFUSION IMPLANTATION SURGERY, THE SURGEON REPORTED THAT THE TAPERED CATHETER WAS MISSING ONE OF THE THREE BEADS USED TO SUTURE THE CATHETER IN PLACE. THE CATHETER WAS DISCARDED AND ANOTHER CATHETER WAS USED IN PLACE. THERE WAS NO IMPACT TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10681146 ↗
• MalfunctionOct 2, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  DURING A CONVERSATION BETWEEN THE REPORTING PHYSICIAN AND INTERA ON (B)(6) 2020, THE REPORTER STATED THEY WERE HAVING ISSUES WITH CODMAN TAPERED CATHETER FOR HAI PATIENTS USING THE MEDTRONIC SYNCHROMED II PUMP. FOLLOW UP COMMUNICATION BETWEEN INTERA AND THE REPORTER ENSUED AND IT WAS EVENTUALLY DISCUSSED THAT THERE WERE 4 PATIENTS OUT OF 310 THAT HAD TEARS IN THE TAPERED CATHETER. THE TAPERED CATHETER COMES WITH A BARBED CONNECTOR AND IS USED TO CONNECT THE CATHETERS. THEY INDICATED THAT THE CONNECTION BETWEEN THE CATHETERS WAS NOT AN ISSUE. AFTER SEVERAL MONTHS (RANGING FROM 3-20 MONTHS FOR EACH PATIENT), THE METAL FLANGE ON THE BARBED CONNECTOR WOULD TEAR THROUGH THE TAPERED CATHETER, AND CONFIRMED BY EITHER NUCLEAR MEDICINE OR DYE STUDY. THREE PATIENTS HAD FINISHED ADJUVANT THERAPY AND THUS THERE WAS NO ADVERSE EVENT REPORTED AT THIS TIME. ONE PATIENT HAD THERAPY INTERRUPTED DUE TO THE CLOT IN THE CATHETER AND THUS WAS UNABLE TO CONTINUE ADJUVANT THERAPY. THE REPORTER STATED THAT THEY BELIEVED THAT THE TEAR WAS NOT CAUSED BY A DEFECT IN THE CATHETER, BUT WAS CAUSED BY THE ACUTE ANGLE OF PLACEMENT OF THE CONNECTOR BETWEEN THE TAPERED CATHETER AND THE MEDTRONIC SYNCHROMED II PUMP

  Patient problems: Failure of Implant

  MAUDE report 10623869 ↗
• MalfunctionOct 2, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  DURING A CONVERSATION BETWEEN THE REPORTING PHYSICIAN AND INTERA ON (B)(6) 2020, THE REPORTER STATED THEY WERE HAVING ISSUES WITH CODMAN TAPERED CATHETER FOR HAI PATIENTS USING THE MEDTRONIC SYNCHROMED II PUMP. FOLLOW UP COMMUNICATION BETWEEN INTERA AND THE REPORTER ENSUED AND IT WAS EVENTUALLY DISCUSSED THAT THERE WERE 4 PATIENTS OUT OF 310 THAT HAD TEARS IN THE TAPERED CATHETER. THE TAPERED CATHETER COMES WITH A BARBED CONNECTOR AND IS USED TO CONNECT THE CATHETERS. THEY INDICATED THAT THE CONNECTION BETWEEN THE CATHETERS WAS NOT AN ISSUE. AFTER SEVERAL MONTHS (RANGING FROM 3-20 MONTHS FOR EACH PATIENT), THE METAL FLANGE ON THE BARBED CONNECTOR WOULD TEAR THROUGH THE TAPERED CATHETER, AND CONFIRMED BY EITHER NUCLEAR MEDICINE OR DYE STUDY. THREE PATIENTS HAD FINISHED ADJUVANT THERAPY AND THUS THERE WAS NO ADVERSE EVENT REPORTED AT THIS TIME. ONE PATIENT HAD THERAPY INTERRUPTED DUE TO THE CLOT IN THE CATHETER AND THUS WAS UNABLE TO CONTINUE ADJUVANT THERAPY. THE REPORTER STATED THAT THEY BELIEVED THAT THE TEAR WAS NOT CAUSED BY A DEFECT IN THE CATHETER, BUT WAS CAUSED BY THE ACUTE ANGLE OF PLACEMENT OF THE CONNECTOR BETWEEN THE TAPERED CATHETER AND THE MEDTRONIC SYNCHROMED II PUMP

  Patient problems: Failure of Implant

  MAUDE report 10623852 ↗
• MalfunctionOct 2, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  DURING A CONVERSATION BETWEEN THE REPORTING PHYSICIAN AND INTERA ON (B)(6) 2020, THE REPORTER STATED THEY WERE HAVING ISSUES WITH CODMAN TAPERED CATHETER FOR HAI PATIENTS USING THE MEDTRONIC SYNCHROMED II PUMP. FOLLOW UP COMMUNICATION BETWEEN INTERA AND THE REPORTER ENSUED AND IT WAS EVENTUALLY DISCUSSED THAT THERE WERE 4 PATIENTS OUT OF 310 THAT HAD TEARS IN THE TAPERED CATHETER. THE TAPERED CATHETER COMES WITH A BARBED CONNECTOR AND IS USED TO CONNECT THE CATHETERS. THEY INDICATED THAT THE CONNECTION BETWEEN THE CATHETERS WAS NOT AN ISSUE. AFTER SEVERAL MONTHS (RANGING FROM 3-20 MONTHS FOR EACH PATIENT), THE METAL FLANGE ON THE BARBED CONNECTOR WOULD TEAR THROUGH THE TAPERED CATHETER, AND CONFIRMED BY EITHER NUCLEAR MEDICINE OR DYE STUDY. THREE PATIENTS HAD FINISHED ADJUVANT THERAPY AND THUS THERE WAS NO ADVERSE EVENT REPORTED AT THIS TIME. ONE PATIENT HAD THERAPY INTERRUPTED DUE TO THE CLOT IN THE CATHETER AND THUS WAS UNABLE TO CONTINUE ADJUVANT THERAPY. THE REPORTER STATED THAT THEY BELIEVED THAT THE TEAR WAS NOT CAUSED BY A DEFECT IN THE CATHETER, BUT WAS CAUSED BY THE ACUTE ANGLE OF PLACEMENT OF THE CONNECTOR BETWEEN THE TAPERED CATHETER AND THE MEDTRONIC SYNCHROMED II PUMP

  Patient problems: Failure of Implant

  MAUDE report 10623841 ↗
• MalfunctionOct 2, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  DURING A CONVERSATION BETWEEN THE REPORTING PHYSICIAN AND INTERA ON (B)(6) 2020, THE REPORTER STATED THEY WERE HAVING ISSUES WITH CODMAN TAPERED CATHETER FOR HAI PATIENTS USING THE MEDTRONIC SYNCHROMED II PUMP. FOLLOW UP COMMUNICATION BETWEEN INTERA AND THE REPORTER ENSUED AND IT WAS EVENTUALLY DISCUSSED THAT THERE WERE 4 PATIENTS OUT OF 310 THAT HAD TEARS IN THE TAPERED CATHETER. THE TAPERED CATHETER COMES WITH A BARBED CONNECTOR AND IS USED TO CONNECT THE CATHETERS. THEY INDICATED THAT THE CONNECTION BETWEEN THE CATHETERS WAS NOT AN ISSUE. AFTER SEVERAL MONTHS (RANGING FROM 3-20 MONTHS FOR EACH PATIENT), THE METAL FLANGE ON THE BARBED CONNECTOR WOULD TEAR THROUGH THE TAPERED CATHETER, AND CONFIRMED BY EITHER NUCLEAR MEDICINE OR DYE STUDY. THREE PATIENTS HAD FINISHED ADJUVANT THERAPY AND THUS THERE WAS NO ADVERSE EVENT REPORTED AT THIS TIME. ONE PATIENT HAD THERAPY INTERRUPED DUE TO THE CLOT IN THE CATHETER AND THUS WAS UNABLE TO CONTINUE ADJUVANT THERAPY. THE REPORTER STATED THAT THEY BELIEVED THAT THE TEAR WAS NOT CAUSED BY A DEFECT IN THE CATHETER, BUT WAS CAUSED BY THE ACUTE ANGLE OF PLACEMENT OF THE CONNECTOR BETWEEN THE TAPERED CATHETER AND THE MEDTRONIC SYNCHROMED II PUMP C

  Patient problems: Failure of Implant

  MAUDE report 10623838 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P800036, P890055. One submission often covers many models, so check the product and lot details in each record.

• Z-2580-2026 · May 11, 2026 · Completed
  Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
• Z-1522-2022 · Jul 10, 2022 · Terminated
  INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
• Z-1571-2014 · Nov 10, 2015 · Terminated
  MedStream Programmable Infusion Pump, 20 mL, Product Code: 91-4200 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for th
• Z-1572-2014 · Nov 10, 2015 · Terminated
  MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for th
• Z-1684-2015 · Mar 5, 2015 · Terminated
  CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump CATALOG NO. : AP-07014 Each CODMAN 3000 Refill Kit cont
• Z-2300-2013 · Aug 13, 2013 · Terminated
  MedStream Programmable Pump; 20ml Pump EMEA 91-4200 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for th
• Z-2293-2013 · Aug 13, 2013 · Terminated
  MedStream Programmable Pump; 20ml - 91-4200US Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intr
• Z-2298-2013 · Aug 13, 2013 · Terminated
  MedStream Refill Kit, U.S (6 units): 91-4288 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intra
• Z-2297-2013 · Aug 13, 2013 · Terminated
  MedStream Refill Kit (6 units), EMEA: 91-4290 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intr
• Z-2295-2013 · Aug 13, 2013 · Terminated
  MedStream Refill Kit, U.S: 91-4287 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal del
• Z-2294-2013 · Aug 13, 2013 · Terminated
  MedStream Programmable Pump; 40ml - 91-4201US Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal
• Z-2299-2013 · Aug 13, 2013 · Terminated
  MedStream Programmable Pump; 40ml Pump EMEA 91-4201 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for th
• Z-2296-2013 · Aug 13, 2013 · Terminated
  MedStream Refill Kit (1 unit), EMEA: 91-4289 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intra
• Z-1690-2013 · Jun 7, 2013 · Terminated
  MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) US 91-4200. Intended for the intrathecal de
• Z-1691-2013 · Jun 7, 2013 · Terminated
  MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine Product Code: 91-4201US (40ml pump) 91-4201 (40ml pump) Intended for the in