Medtronic IsoMed Implantable Constant-Flow Infusion Pump… recallZ-1153-2008 · Medtronic Neuromodulation · initiated Jan 16, 2008

Why it was recalled

Device/Drug Interaction - The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of intrathecal catheters which infuse opioids, baclofen, or chemotherapy drugs into patients. On January 16, 2008, Medtronic sent a letter to doctors who implant these d

FDA root cause category: Device Design

What the company is doing

An Urgent Medial Device Correction letter was sent January 16, 2008, to Health Care Professionals. The letter describes the incidences, symptoms and recommendations for patient management. Excerpts from the approved Medtronic Professional Labeling are also included with the letter. The firm has requested unreported inflammatory mass in a patient with a Medtroinc device to the firm and to the FDA MedWatch Program by phone at 1-800-FDA-1088. Additional assistance may be obtained by contacting Medtronic Neuromodulation Technical Services at 1-800-707-0933.

Recall details

Recall number

Z-1153-2008

Recall class

Not yet classified by the FDA

Status

Terminated

Initiated by the company

Jan 16, 2008

Posted by the FDA

Mar 22, 2008

Recalling firm

Medtronic Neuromodulation

Quantity

~102,792 worldwide. 90,330 within US and 12,462 OUS

Product code

LKK

FDA submissions

P860004, P990034

Distribution

Worldwide Distribution -- USA including states of Washington D.C., Puerto Rico, and countries of Aruba, Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Faroe Islands, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Malta, Mexico, Netherlands, Netherlands Antilles, New Caledonia, Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia and Montenegro, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vatican City State.

Product description

Medtronic IsoMed Implantable Constant-Flow Infusion Pump, model 8472-35. The contents of the inner package have been sterilized by ethylene oxide gas. Reservoir size: 35 mL. Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA. The implantable Medtronic IsoMed Constant-Flow Infusion Pump is part of the IsoMed Constant-Flow Infusion System designed to contain and administer parenteral drugs to a specific site. The components of the IsoMed Constant-Flow Infusion System include the pump, Medtronic catheter, catheter accessories, Medtronic Refill kit, and Medtronic catheter access port kit. IsoMed pumps are implantable devices that store and dispense drugs according to a constant flow rate set during the manufacturing process.

Other devices under the same FDA submission

51 devices cleared under P860004, P990034 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• SYNCHROMED® II 8637-40

  Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  1 recall7 deaths4,929 reports
• SYNCHROMED® II 8637-20

  Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  2 recalls5 deaths4,303 reports
• SYNCHROMED ® II 8637-40

  Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  1 recall6 deaths4,119 reports
• SYNCHROMED® II 8637-40

  Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  2 recalls10 deaths3,054 reports
• SYNCHROMED ® II 8637-20

  Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  1 recall4 deaths3,084 reports
• SYNCHROMED® II 8637-20

  Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  2 recalls1 death2,588 reports
• SynchroMed® II 8637-40

  Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  1 recall6 deaths2,291 reports
• SYNCHROMED® II 8637-20

  Medtronic, Inc. · Pump, infusion, implanted, programmable
  1 recall3 deaths2,242 reports
• SYNCHROMED® II 8637-40

  Medtronic, Inc. · Pump, infusion, implanted, programmable
  1 recall4 deaths1,964 reports
• SynchroMed® II 8637-20

  Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  1 recall4 deaths1,920 reports
• SYNCHROMED™ III 8667-20

  Medtronic, Inc. · Pump, infusion, implanted, programmable
  1 death1,937 reports
• SYNCHROMED ® II 8637-20

  Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
  2 deaths1,766 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 46685).

• Z-1142-2008 · Terminated
  Medtronic - SynchroMed EL Implantable Infusion Pump, Model Number: 8626-10. The contents of the inner package have been sterilized by ethylene oxide gas. 10 mL pump with reservoi…
• Z-1143-2008 · Terminated
  Medtronic SynchroMed EL Implantable Infusion Pump, model 8626-18. The contents of the inner package have been sterilized by ethylene oxide gas. 18 mL pump with reservoir valve. …
• Z-1144-2008 · Terminated
  Medtronic SynchroMed EL Implantable Infusion Pump, model 8626L-10. The contents of the inner package have been sterilized by ethylene oxide gas. 10 mL pump with reservoir valve a…
• Z-1145-2008 · Terminated
  Medtronic SynchroMed EL Implantable Infusion Pump, model 8626L-18. The contents of the inner package have been sterilized by ethylene oxide gas. 18 mL pump with reservoir valve a…
• Z-1146-2008 · Terminated
  Medtronic SynchroMed EL Implantable Infusion Pump, model 8627-10. The contents of the inner package have been sterilized by ethylene oxide gas. 10 mL pump with reservoir valve an…
• Z-1147-2008 · Terminated
  Medtronic SynchroMed EL Implantable Infusion Pump, model 8627-18. The contents of the inner package have been sterilized by ethylene oxide gas. 18 mL pump with reservoir valve an…
• Z-1148-2008 · Terminated
  Medtronic SynchroMed EL Implantable Infusion Pump, model 8627L-10. The contents of the inner package have been sterilized by ethylene oxide gas. 10 mL pump with reservoir valve, …
• Z-1149-2008 · Terminated
  Medtronic SynchroMed EL Implantable Infusion Pump, model 8627L-18. The contents of the inner package have been sterilized by ethylene oxide gas. 18 mL pump with reservoir valve, …
• Z-1150-2008 · Terminated
  Medtronic SynchroMed II Programmable Pump, model 8637-20. The contents of the inner package have been sterilized by ethylene oxide gas. 20 mL reservoir. Medtronic, Inc., 710 Me…
• Z-1151-2008 · Terminated
  Medtronic SynchroMed II Programmable Pump, model 8637-40. The contents of the inner package have been sterilized by ethylene oxide gas. 40 mL reservoir. Medtronic, Inc., 710 Me…
• Z-1152-2008 · Terminated
  Medtronic IsoMed Implantable Constant-Flow Infusion Pump, model 8472-20. The contents of the inner package have been sterilized by ethylene oxide gas. Reservoir size: 20 mL. M…
• Z-1154-2008 · Terminated
  Medtronic IsoMed Implantable Constant-Flow Infusion Pump, model 8472-60. The contents of the inner package have been sterilized by ethylene oxide gas. Reservoir size: 60 mL. M…