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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86988

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 08, 2020
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Medtronic Neurosurgery

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

Z-0738-2021
Recall number
Z-0738-2021
Initiated
December 08, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Neurosurgery
Quantity
3,165 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
seal of the outer pouch of catheters. The defect may compromise the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention.

Code information

Lot Numbers: 0010052549, 0010289829, 0010305920, 0010353501, 0010384893, 0010052552, 0010289830, 0010305921, 0010353502, 0010384894, 0010149011, 0010289831, 0010305923, 0010353503, 0010384895, 0010149013, 0010289833, 0010305926, 0010353504, 0010384896, 0010258434, 0010289834, 0010316955,, 0010369362, 0010393213, 0010265136, 0010297686, 0010316956, 0010369364, 0010393215, 0010265137, 0010297689, 0010316957, 0010369365, 0010393216, 0010265138, 0010297691, 0010316958, 0010376787, 0010393814, 0010278408, 0010297693, 0010336617, 0010376788, 0010393839, 0010278409, 0010297696, 0010336618, 0010376789, 0010289827, 0010305912, 0010336619, 0010376790, 0010289828, 0010305919, 0010353500, 0010384892

Distribution pattern

Worldwide Distribution. US nationwide, Albania, Argentina, Armenia, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, Germany, Greece, Guam, Hong Kong, Hungary, India, Islamic Republic of Iran, Ireland, Israel, Italy, Latvia, Macao, Malaysia, Mauritius, Republic of Moldova, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam

device · product 2 of 3

Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

Z-0739-2021
Recall number
Z-0739-2021
Initiated
December 08, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Neurosurgery
Quantity
1,926 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
seal of the outer pouch of catheters. The defect may compromise the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention.

Code information

Lot numbers: 0010258435, 0010281390, 0010312360, 0010353505, 0010384900, 0010273889, 0010281391, 0010312361, 0010353507, 0010384901, 0010273890, 0010281392, 0010312362, 0010369366, 0010384903, 0010273891, 0010289835, 0010316959, 0010369367, 0010393220, 0010273893, 0010289836, 0010316960, 0010376784, 0010393221, 0010278418, 0010297678, 0010316961, 0010376785, 0010278427, 0010305929, 0010316963, 0010376786, 0010281384, 0010305937, 0010336620, 0010384897

Distribution pattern

Worldwide Distribution. US nationwide, Albania, Argentina, Armenia, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, Germany, Greece, Guam, Hong Kong, Hungary, India, Islamic Republic of Iran, Ireland, Israel, Italy, Latvia, Macao, Malaysia, Mauritius, Republic of Moldova, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam

device · product 3 of 3

Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only. Used in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

Z-0740-2021
Recall number
Z-0740-2021
Initiated
December 08, 2020
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Neurosurgery
Quantity
3,858 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
seal of the outer pouch of catheters. The defect may compromise the sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for a defect on the seal of the outer pouch of catheters. The defect may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention.

Code information

Lot Numbers: 0010038455, 0010258429, 0010289822, 0010316971, 0010376783, 0010061294, 0010258430, 0010289823, 0010316972, 0010384872, 0010061295, 0010258433, 0010297674, 0010316973, 0010384874, 0010083617, 0010265129, 0010297675, 0010336621, 0010384881, 0010083618, 0010265130, 0010297676, 0010336622, 0010384888, 0010083619, 0010265131, 0010297683, 0010336623, 0010393228, 0010083620, 0010265133, 0010305904, 0010353498, EB00006085, 0010083622, 0010265134, 0010305905, 0010353499, EB00006086, 0010083623, 0010265135, 0010305906, 0010369357, EB00006166, 0010097240, 0010278428, 0010305907, 0010369358, EB00007496, 0010097241, 0010278430, 0010305908, 0010369359, EB00007537, 0010097249, 0010281382, 0010305909, 0010376779, EB00009476, 0010097250, 0010281383, 0010316967, 0010376781, 0010097251, 0010289819, 0010316968, 0010376782

Distribution pattern

Worldwide Distribution. US nationwide, Albania, Argentina, Armenia, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, Germany, Greece, Guam, Hong Kong, Hungary, India, Islamic Republic of Iran, Ireland, Israel, Italy, Latvia, Macao, Malaysia, Mauritius, Republic of Moldova, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam