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  5. Pressure Monitoring Device Recall: Medtronic Neurosurgery Issues Correction for Becker and Exacta External Drainage and Monitoring Systems Due to Cracks And/Or Leaks in Stopcocks
  1. Medical Device Recalls

Pressure Monitoring Device Recall: Medtronic Neurosurgery Issues Correction for Becker and Exacta External Drainage and Monitoring Systems Due to Cracks And/Or Leaks in Stopcocks

This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.

Affected Product

Figure 1: Example Becker System with labeled stopcock locations.
  • Product Names: Becker External Drainage and Monitoring System, Exacta External Drainage and Monitoring System (EDMS)
  • Unique Device Identifier (UDI)/Model: See full list of affected products.

What to Do  

  • Inspect all Becker and Exacta EDMS devices for cracks or leaks.
  • If there are cracks and/or leaks, do not use the these devices. 
  • Monitor all patients with EDMS for evidence of infection. 

In November 2024, Medtronic Neurosurgery sent all affected customers an Urgent Medical Device Correction recommending the following actions:

For providers

  • Inspect all stopcocks and connections before use to make sure connections are secure and there are no visible cracks.
  • Do not use the device if cracks or leaks are identified. Return it to Medtronic.
  • Pre-fill the system with sterile isotonic saline solution before connecting to the patient.
  • Check all connections to make sure fittings (connections) are finger-tight and leak-free.
  • Finger tighten all connections. Over tightening can cause cracks and leaks. 
  • Allow device to air dry completely after cleaning with alcohol or a disinfectant containing alcohol. 
  • Replace any system that develops cracks or leaks during use using sterile technique. Return the damaged system to Medtronic. 
    • Consider application of hemostat or other clamp to the proximal patient line during replacement if blocking the patient line will not create patient risk. 
  • Monitor all patients with EDMS for evidence of infection. 
  • Replace any system with cracks or leaks and continue monitoring the patient for evidence of infection.

For customers

  • Complete and return the enclosed customer confirmation form to acknowledge the letter. 
  • Post a copy of the notification near impacted product as a reminder of the issue and recommended actions. 
  • Keep a copy of the letter and completed response form for institutional records.
  • Contact Medtronic Customer Service via email: rs.jaxcustomerservice@medtronic.com, or phone: 1-800-874-5797 Option 1, and mention FA1452, <Lot Number and Product Number> to initiate the returns process.

Medtronic will honor return of unused product for a full credit. 

Reason for Recall  

Medtronic Neurosurgery is recalling certain Becker and Exacta EDMS due to a risk for cracks and or leaks in device stopcocks. 

The use of affected product may cause serious adverse health consequences, including leaks of cerebrospinal fluid, infections, and death.  
 
There have been 15 reported injuries. There have been no reports of death.  

Device Use

Becker and Exacta External Drainage and Monitoring Systems (EDMS) provide a complete closed system to drain cerebrospinal fluid (CSF) from specific parts of the brain and to monitor CSF pressure and flow rate from these areas. 

Contact Information  

Customers in the U.S. with questions about this recall should contact their Medtronic representative or Medtronic Technical Support at 1-888-826-5603 (reference FA1452). 

Full List of Affected Devices (if applicable)  

Product Names Medtronic Product Number (REF)   GTIN
EDMS 24146 BECKER NO Y-SITEEDMS 24146 BECKER NO Y-SITE 2414600763000333423
EDMS 24146 BECKER NO Y-SITE 2414600763000572839
EDMS II 25120 BECKER W/1-WAY VALVE2512000763000333430 
EDMS II 25120 BECKER W/1-WAY VALVE2512000763000431297
KIT 26040 BECKER EDMS II2604000763000333447 
KIT 26040 BECKER EDMS II2604000763000406066 
KIT 27581 EXACTA W/EDM VCATH 35CM27581  00763000333478
BECKER 27609 W/NEEDLESLESS INJ. SITE 2760900763000333485
BECKER 27609 W/NEEDLESLESS INJ. SITE 2760900763000529307 
EDM 27636 EXACTA W/BRAIDED CORD LOCK 27636 00763000333492
EDM 27666 EXCTA W GLUE STPCK GR PT LN2766600763000333515
BECKER 27670 STOP BELOW DC NDL-LS IN2767000763000333522 
BECKER 27670 STOP BELOW DC NDL-LS IN 2767000763000529314
BECKER 27672 ONEWAY VLV Y-SITE PT LN2767200763000333539 
EDMS 27702 EURO BECKER II GR PT LN2770200763000333553 
EDMS 27702 EURO BECKER II GR PT LN 2770200763000467326
EDM 27732 EXACTA W/NDL-LS INJ. ST W/CAP27732 00763000333560 
BECKER 27761 STOP BCNDLESS PATLN 24 2776100763000333577 
BECKER 27761 STOP BCNDLESS PATLN 24 2776100763000529338
BECKER 27767 NO STPCOCK ON PTLN 63 27767 00763000333584 
EDMS 27779 BECKER BC NDLESS BOND CONN27779 00763000333591
EDMS 27779 BECKER BC NDLESS BOND CONN27779 00763000529345
EDMS 27785 EXACTA 50ML BC NDLESS INJ27785 00763000333607
EDMS 27795 EXACTA 100ML CATH2779500763000333614 
EDMS 27811 BECKER GRN PL VCATH2781100763000333638 
EDMS 27861 EXACTA 50ML ANTIRFLUX GRNPL27861 00763000333645
EDMS 27873 BECKR W/SC BLW DC W/NLESS INJ27873 00763000333652
EDMS 27931 BECKER GS TUBING SMARTSITES 2793100763000333669 
EDMS 27931 BECKER GS TUBING SMARTSITES 2793100763000467364
EDMS 46128 BECKER II BLUE PT LN46128 00763000333676 
EDMS 46128 BECKER II BLUE PT LN 46128  00763000406073 
EDMS 46129 EURO BECKER II BLUE PT LN46129  00763000333683
EDMS 46129 EURO BECKER II BLUE PT LN46129  00763000431259 
SYSTEM 46700 EXACTA DISP. DRAINAGE4670000763000333690
SYSTEM 46705 EXACTA DRAINAGE 100ML4670500763000333706

Additional FDA Resources (listed in order of most to least recent):  

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. 

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