MEDSTREAM 91-4201USRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704064930), received between Dec 14, 2018 and Mar 25, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Defective Alarm” (1 report).

15 other recalls cover devices cleared under the same FDA submission (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THERE WAS AN OVERDOSE EVENT CREATED BY THE 40 ML MEDSTREAM PUMP (914201/LOT# CLKBJ8). THE PATIENT WAS REPORTED TO HAVE BEEN IN THE HOSPITAL RECEIVING MEDICAL TREATMENT; THE DURATION OF THE PATIENT HOSPITALIZATION IS NOT KNOWN. IT WAS REPORTED THAT THE PATIENT IS FEELING WELL AGAIN AND IS BACK ON TRACK. THE MEDSTREAM PUMP HAS BEEN DEACTIVATED. THE LAST REFILL DATE WAS ON (B)(6) 2019. INFORMATION RELATED TO THE REFILL PROCEDURE AND DEVICES USED DURING THE REFILL WAS ALSO NOT AVAILABLE. IT WAS REPORTED THAT THERE WERE STILL 32 ML OF THE DRUG IN THE PUMP RESERVOIR, BUT THE PHYSICIAN EXPECTED A VOLUME LESS THAN 32 ML. THE PATIENT RECEIVED THE PUMP IMPLANT ON (B)(6) 2011. INFORMATION RELATED TO THE MEDICATION THAT WAS BEING DELIVERED/ADMINISTERED BY THE MEDSTREAM PUMP, THE DOSAGE OF THE MEDICATION, AND ITS FLOW RATE ARE NOT AVAILABLE. IT IS NOT KNOWN IF THE PUMP IS AVAILABLE FOR RETURN. THE PHYSICIAN IS NOT ABLE TO PROVIDE THE PUMP TRANSACTION LOGS.

  Patient problems: Overdose

  MAUDE report 8449667 ↗
• InjuryJan 2, 2019Pumping Problem; Pumping Problem

  THE HEALTHCARE PROFESSIONAL REPORTED ON (B)(6) 2018, THE PATIENT WENT IN THE HOSPITAL WHEN HIS IMPLANTED 40 ML MEDSTREAM PUMP (914201 / (B)(4)) THAT WAS IMPLANTED IN 2015, BEGAN TO ¿SQUEAK.¿ THE PUMP IS USED TO ADMINISTER BACLOFEN. THE PATIENT WAS ADMITTED FOR OBSERVATION PURPOSES. THE MEDSTREAM PUMP REMAINS IMPLANTED. THE SCREEN ERROR THE PHYSICIAN READ WAS, ¿PUMP HARDWARE FAILURE [8], EMPTY THE PUMP RESERVOIR AND CONTACT CUSTOMER SUPPORT¿. THERE WAS NO REPORT OF AN ACTUAL OVERDOSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8210328 ↗
• InjuryDec 14, 2018Defective Alarm; Restricted Flow rate; Defective Alarm; Restricted Flow rate

  THE HEALTHCARE PROFESSIONAL REPORTED ON THE AFTERNOON OF (B)(6) 2018, HE RECEIVED INFORMATION THAT THE 40 ML MEDSTREAM PUMP (914201 / (B)(4)) THAT WAS IMPLANTED ON (B)(6) 2014, STOPPED WORKING AFTER THE PATIENT UNDERWENT A MAGNETIC RESONANCE IMAGING (MRI) SCAN. THE NO HARDWARE FAILURE ERROR 11 WAS REPORTED. THE PHYSICIAN WAS ABLE TO RESTART THE PUMP WITHOUT ISSUE. THE PUMP WAS LAST FILLED ON (B)(6) 2018, WITH 40 ML MORPHINE AT A CONCENTRATION OF 10 MG/ML WITH THE DOSE SET AT 3.5 MG/24 HOURS. THE HEALTHCARE PROFESSIONAL ARRANGED AN APPOINTMENT TO RECHECK THE PUMP WITH THE TECHNICAL HARDWARE KEY. THE INITIAL QUERY WAS WITHOUT ISSUE. SUBSEQUENT TEST SHOWED THAT THE PUMP SELF-TEST STOPPED WITHOUT GIVING AN ERROR MESSAGE. THE PUMP RUNS A SELF-TEST THREE TIMES PER DAY; THIS SELF-TEST STEP STOPPED WORKING IN THE AFTERNOON OF (B)(6) 2018. AFTER CONSULTATION WITH THE ATTENDING PHYSICIAN, IT WAS RECOMMENDED THAT THE PUMP BE REMOVED. THE PATIENT WILL RECEIVE ORAL MEDICATION UNTIL EXPLANTATION SURGERY. THE MEDSTREAM PUMP WAS EXPLANTED ON (B)(6) 2018. IT WAS REPORTED THAT THE EXPLANTED MEDSTREAM PUMP WILL BE AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING.

  Patient problems: No Code Available

  MAUDE report 8166805 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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-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-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-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-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-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-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-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-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-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
• 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