Class II recall Z-0267-2027: Medtronic Neuromodulation

Class II recall Z-0267-2027: Medtronic Neuromodulation (Minnesota): Medtronic Neuromodulation. Dated 7 days ago, it is inside the fresh trigger window. Score 68/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).

Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

Free preview: all 14 published fields of this record are shown below. Locked: 11 related MN FDAPulse records and the 5-column CSV export.

FieldValue
RecordDevice recall
Recall numberZ-0267-2027
Recalling firmMedtronic Neuromodulation
ClassificationClass II
StatusOngoing
Voluntary / mandatedVoluntary: Firm initiated
SpecialtyOther
ProductInterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO PERC 3560030
ReasonWrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may result in delay of surgery or need for surgical replacement of the product.
Quantity56,331 (US); 40,211 (OUS)
DistributionWorldwide distribution - US Nationwide and territory of Puerto Rico. The countries of Brazil, Colombia, Chile, Canada, Japan, New Zealand, Australia, United Kingdom, Switzerland, Sweden, Spain, Portugal, Italy, Israel, Germany, France, Finland, Canary Islands, Belgium, Austria, Norway, Northern Irel
Recall initiated2026-09-08
Reported2026-10-28
Firm locationMinneapolis, MN, United States
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  • Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
  • Record date: 2026-10-28
  • Data refreshed: 2026-11-03
  • Refunds on request within 14 days

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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT

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Peer benchmark and outreach value: Class II recall Z-0267-2027: Medtronic Neuromodulation and 12 Minnesota peers

  • Minnesota FDAPulse records like this one: 12
  • Timing: High: dated in the last 7 days
  • Estimated pipeline if you contact every Minnesota peer: $2,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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68 / 100 Predicate Speed & CAPA Advisory Opportunity Score

  • Class II recall: usually triggers CAPA and quality-system remediation work.
  • Recall is still ongoing.
  • Posted 7 days ago.

What is the FDAPulse record for Class II recall Z-0267-2027: Medtronic Neuromodulation in Minnesota?

Class II device recall Z-0267-2027 by Medtronic Neuromodulation: Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the sy

How does Class II recall Z-0267-2027: Medtronic Neuromodulation compare to other Minnesota FDAPulse records?

It is fresh: dated 7 days ago, inside the window where early outreach matters most.

Class II recall Z-0267-2027 vs. top 3 peers

OrganizationLocationRecord date
Class II recall Z-0267-2027MN2026-10-28
Class II recall Z-3155-2026MA2026-10-07
Class II recall Z-0232-20272026-10-28
Class II recall Z-0243-20272026-10-28

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