PlainRecalls
ModerateClass IIOngoing

FDA Devices recall · Reported September 25, 2024

2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product Description: PROGRAMMER 209031 PORTABLE CRM; c) 2090AA, Product Description: PROGRAMMER 2090AA PORTABLE CRM; d) 2090AA4, Product Description: 2090AA4 PROGRAMMER-PORTABLE CRM; e) 2090AC, Product Description: SFTWR 2090AC PROGRAMMER-PORTABLE CRM W/; f) 2090AM, Product Description: PROGRAMMER CARELINK HONG KONG ASIA; g) 2090CHEN, Pro

Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen capability is enabled by soft…

Recall #
Z-3152-2024
Affected scope
18788 units
Initiated
July 11, 2024
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Medtronic Inc. recalled 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Descripti… - a moderate-severity action.

2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Descripti… was recalled by Medtronic Inc. in September 25, 2024. Reason: Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomo…. Check the official notice for the remedy. Verify recall #Z-3152-2024 with the FDA Devices before acting.

The recall

Medtronic Inc. issued this moderate-severity FDA Devices recall-Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomo….

Moderate
severity level
19K units
affected scope
Class II
classification
September 25, 2024
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-3152-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product Description: PROGRAMMER 209031 PORTABLE CRM; c) 2090AA, Product Description: PROGRAMMER 2090AA PORTABLE CRM; d) 2090AA4, Product Description: 2090AA4 PROGRAMMER-PORTABLE CRM; e) 2090AC, Product Description: SFTWR 2090AC PROGRAMMER-PORTABLE CRM W/; f) 2090AM, Product Description: PROGRAMMER CARELINK HONG KONG ASIA; g) 2090CHEN, Product Description: PRGM 2090CHEN PKG-ASSY PROGRAMMER 2090; h) 2090CHFR, Product Description: PRGM 2090CHFR PKG-ASSY PROGRAMMER 2090; i) 2090CL, Product Description: PROGRAMMER 2090CL INTL-JAPAN MKT; j) 2090EN, Product Description: PRGM 2090EN PKG-ASSY PROGRAMMER 2090 UK; k) 2090FR, Product Description: PRGM 2090FR PKG-ASSY PROGRAMMER 2090 IN; l) 2090LDEN, Product Description: PRGM 2090LDEN PROGRAMMER-PORTABLE LOANE; m) 2090NL, Product Description: PRGM 2090NL PKG-ASSY PROGRAMMER 2090 IN; n) 2090W, Product Description: PROGRAMMER 2090W TELEMETRY C; o) 2090WCHDE, Product Description: PROGRAMMER 2090WCHDE SWISS-GERMAN; p) 2090WCHEN, Product Description: PROGRAMMER 2090WCHEN SWISS-ENGLISH; q) 2090WCHFR, Product Description: PROGRAMMER 2090WCHFR SWISS-FRENCH; r) 2090WDE, Product Description: PROGRAMMER 2090WDE GERMAN MKT; s) 2090WFR, Product Description: PROGRAMMER 2090WFR FRENCH MKT; t) 2090WLD, Product Description: PROG 2090WLD ALL LANGUAGES W/ANALYZER; u) 2090WNL, Product Description: PROGRAMMER 2090WNL NETHERLANDS MKT

Reason for recall

Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen capability is enabled by software version 3.2 or higher.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Ongoing
Recall number Z-3152-2024
Date reported September 25, 2024
Date initiated July 11, 2024
Recalling firm Medtronic Inc.
Firm location Mounds View, MN
Affected scope 18788 units
Distribution Worldwide distribution.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

18788 units units affected - limited or regional distribution scale.

Regional (<10K units) -
Multi-state (10K – 100K units) ✓ This recall
Large-scale (100K – 1M units) -
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-3152-2024) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product Description: PROGRAMMER 209031 PORTABLE CRM; c) 2090AA, Product Description: PROGRAMMER 2090AA PORTABLE CRM; d) 2090AA4, Product Description: 2090AA4 PROGRAMMER-PORTABLE CRM; e) 2090AC, Product Description: SFTWR 2090AC PROGRAMMER-PORTABLE CRM W/; f) 2090AM, Product Description: PROGRAMMER CARELINK HONG KONG ASIA; g) 2090CHEN, Product Description: PRGM 2090CHEN PKG-ASSY PROGRAMMER 2090; h) 2090CHFR, Product Description: PRGM 2090CHFR PKG-ASSY PROGRAMMER 2090; i) 2090CL, Product Description: PROGRAMMER 2090CL INTL-JAPAN MKT; j) 2090EN, Product Description: PRGM 2090EN PKG-ASSY PROGRAMMER 2090 UK; k) 2090FR, Product Description: PRGM 2090FR PKG-ASSY PROGRAMMER 2090 IN; l) 2090LDEN, Product Description: PRGM 2090LDEN PROGRAMMER-PORTABLE LOANE; m) 2090NL, Product Description: PRGM 2090NL PKG-ASSY PROGRAMMER 2090 IN; n) 2090W, Product Description: PROGRAMMER 2090W TELEMETRY C; o) 2090WCHDE, Product Description: PROGRAMMER 2090WCHDE SWISS-GERMAN; p) 2090WCHEN, Product Description: PROGRAMMER 2090WCHEN SWISS-ENGLISH; q) 2090WCHFR, Product Description: PROGRAMMER 2090WCHFR SWISS-FRENCH; r) 2090WDE, Product Description: PROGRAMMER 2090WDE GERMAN MKT; s) 2090WFR, Product Description: PROGRAMMER 2090WFR FRENCH MKT; t) 2090WLD, Product Description: PROG 2090WLD ALL LANGUAGES W/ANALYZER; u) 2090WNL, Product Description: PROGRAMMER 2090WNL NETHERLANDS MKT. Recalled by Medtronic Inc.. Units affected: 18788 units.
Why was this product recalled?
Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen capability is enabled by software version 3.2 or higher.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 25, 2024. Severity: Moderate. Recall number: Z-3152-2024.
Where was the recalled product distributed?
Distribution: Worldwide distribution..
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

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This recall: FDA Devices, reported September 25, 2024. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026